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RADIOMETER AMERICA, INC.

Last updated September 17, 2026

What RADIOMETER AMERICA, INC. makes

The company manufactures arterial blood sampling kits, including portable and modular blood gas analyzers for measuring oxygen, carbon dioxide, pH, electrolytes, and other analytes, as well as controls for quality assurance. It also produces transcutaneous monitors for non-invasive measurement of oxygen and carbon dioxide tension through the skin, alongside dedicated blood gas and electrolyte testing systems.

These devices are regulated under FDA classifications, including Class I and Class II, with submissions documented through 510(k), PMA, and UDI registries. The company’s products are listed in the United States, where it is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Radiometer America, Inc. manufacture?

Radiometer America, Inc. specializes in arterial blood sampling kits and blood gas analysis systems. Their portfolio includes portable and modular blood gas analyzers designed to measure key analytes like oxygen (pO₂), carbon dioxide (pCO₂), pH, and electrolytes. They also produce transcutaneous monitors for non-invasive measurement of oxygen and carbon dioxide tension through the skin, as well as controls for quality assurance in blood gas testing. These devices are primarily used in critical care, emergency medicine, and clinical laboratories.

Where is Radiometer America, Inc. based, and where are their devices regulated?

Radiometer America, Inc. is headquartered in the United States. Their devices fall under FDA regulation, with classifications ranging from Class I to Class II. The company’s products are listed in U.S. regulatory databases, including submissions through 510(k) premarket notifications, PMAs (Premarket Approvals), and UDI (Unique Device Identification) registries, reflecting their compliance with U.S. medical device authorization pathways.

Which regulatory registries list Radiometer America, Inc.’s devices?

Radiometer America, Inc.’s devices are documented in key U.S. regulatory registries, including the FDA’s 510(k) premarket clearance database, PMA submissions for higher-risk devices, and the UDI (Unique Device Identification) system. These registries track submissions required for authorization, ensuring transparency in the device’s regulatory status and compliance with U.S. medical device laws.

How are Radiometer America, Inc.’s devices classified under FDA regulations?

Radiometer America, Inc.’s devices are classified under the FDA’s risk-based system, with most falling into Class I (low risk, generally exempt from premarket review) or Class II (moderate risk, requiring special controls or 510(k) clearance). For example, blood gas analyzers and transcutaneous monitors are typically Class II due to their role in critical patient monitoring, while some sampling kits may qualify as Class I. Classification determines the regulatory pathway, such as 510(k) submissions or PMA for higher-risk innovations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 6836 Engle Rd, Middleburg Heights, OH, 44130
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1523456
DUNS Number: —

Catalogue (61)

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Device	Model / Reference	Registries	Class	Status
Eml 100	K935120	FDA 510(k)	Class II	Active
Oximeter	K871353	FDA 510(k)	Class II	Active
Qualicheck 4	K915399	FDA 510(k)	Class I	Active
Sensititre Indole Reagent	K894776	FDA 510(k)	Class I	Active
Abl300 Acid Base Laboratory	K844295	FDA 510(k)	Class II	Active
Abl520 Blood Gas System	K910827	FDA 510(k)	Class II	Active
Microbact Solid Plate Systems	K923342	FDA 510(k)	Class I	Active
Sensi-Cal Amco Aepa-1	K935566	FDA 510(k)	Class II	Active
Sensititre Susceptibility Enterococcal Vanco Amp	K944753	FDA 510(k)	Class II	Active
Abl500 Blood Gas System	K895181	FDA 510(k)	Class II	Active
Radiometer Tcm-10 Transcutaneous Carbon Dioxide Mo	P800043	FDA PMA	Class II	Active

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FDA Recalls (64)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Radiometer America, Inc. has 64 recall records initiated between January 12, 2005, and July 10, 2019, all marked as terminated. The reasons cited include performance issues such as excessive drift in membrane units, software anomalies affecting patient data matching and result interpretation, design errors in sample type handling, and calibration or labeling inaccuracies. Additional concerns involve software security vulnerabilities, incorrect control ranges in package inserts, physical misfits in analyzer adaptors, and deviations in calibration solutions or membrane readings.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 10, 2019	Z-2320-2019	—	terminated	Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Jul 3, 2018	Z-0682-2019	—	terminated	The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Jul 2, 2018	Z-0801-2019	—	terminated	From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.
May 25, 2018	Z-0010-2019	—	terminated	The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again
Oct 24, 2017	Z-0231-2018	—	terminated	Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
Sep 7, 2017	Z-3237-2017	—	terminated	Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
Jan 26, 2017	Z-1462-2017	—	terminated	Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Jan 26, 2017	Z-1463-2017	—	terminated	Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Nov 23, 2016	Z-0899-2017	—	terminated	Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Dec 29, 2015	Z-0748-2016	—	terminated	The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Nov 18, 2015	Z-1595-2016	—	terminated	Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
Jul 16, 2015	Z-2417-2015	—	terminated	When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
Dec 8, 2014	Z-1046-2015	—	terminated	The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
Oct 29, 2014	Z-1293-2015	—	terminated	Negative drift on QC during in-use lifetime of CREA membranes can be observed.
Oct 20, 2014	Z-0873-2015	—	terminated	Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag
Jul 28, 2014	Z-2597-2014	—	terminated	—
Oct 15, 2013	Z-0816-2014	—	terminated	RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
Jul 5, 2013	Z-1075-2014	—	terminated	RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
Jun 10, 2013	Z-0713-2014	—	terminated	RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.
Nov 27, 2012	Z-1930-2013	—	terminated	RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
Oct 8, 2012	Z-2303-2013	—	terminated	RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
Jul 5, 2012	Z-2162-2012	—	terminated	A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Jul 5, 2012	Z-2164-2012	—	terminated	A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Jul 5, 2012	Z-2163-2012	—	terminated	A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Dec 16, 2011	Z-1008-2012	—	terminated	When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.
Sep 27, 2011	Z-0341-2012	—	terminated	Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
Apr 7, 2011	Z-2571-2011	—	terminated	Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used
Jan 12, 2011	Z-2112-2011	—	terminated	Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the
Nov 1, 2010	Z-1011-2011	—	terminated	Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.
Apr 16, 2009	Z-1554-2009	—	terminated	When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
Mar 26, 2009	Z-1015-2010	—	terminated	Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
Sep 5, 2008	Z-0457-2009	—	terminated	The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
Jan 18, 2008	Z-1653-2008	—	terminated	Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
Jan 18, 2008	Z-1654-2008	—	terminated	Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
Jun 22, 2007	Z-0038-2008	—	terminated	Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.
Jan 16, 2007	Z-0705-2007	—	terminated	In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
Nov 13, 2006	Z-1094-2007	—	terminated	Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem
Nov 13, 2006	Z-1095-2007	—	terminated	Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem
Jul 18, 2006	Z-1443-06	—	terminated	Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
Jul 6, 2006	Z-0115-2007	—	terminated	Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
Jun 29, 2006	Z-1442-06	—	terminated	Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.
Jun 22, 2006	Z-0975-2007	—	terminated	The clinitubes are not able to be filled due to contamination with silicone during production.
Jun 6, 2006	Z-0608-2013	—	terminated	The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
May 22, 2006	Z-1260-06	—	terminated	An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.
May 1, 2006	Z-1261-06	—	terminated	Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.
Apr 7, 2006	Z-1453-06	—	terminated	System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
Mar 22, 2006	Z-1321-06	—	terminated	Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
Mar 22, 2006	Z-1322-06	—	terminated	Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
Nov 1, 2005	Z-1436-06	—	terminated	Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
Oct 31, 2005	Z-1460-06	—	terminated	Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.
Oct 31, 2005	Z-1325-06	—	terminated	ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
Sep 29, 2005	Z-1386-06	—	terminated	Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
Sep 29, 2005	Z-1387-06	—	terminated	Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
Sep 19, 2005	Z-1323-06	—	terminated	Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
Sep 19, 2005	Z-1324-06	—	terminated	Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
Jun 17, 2005	Z-1319-06	—	terminated	The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
Jun 17, 2005	Z-1318-06	—	terminated	Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
Jun 17, 2005	Z-1317-06	—	terminated	Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
Jun 9, 2005	Z-1320-06	—	terminated	The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results.
May 24, 2005	Z-1316-06	—	terminated	The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).
Mar 2, 2005	Z-1262-06	—	terminated	Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
Feb 2, 2005	Z-1437-06	—	terminated	Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.
Feb 1, 2005	Z-1314-06	—	terminated	The CI membrane units generate too low values for status and sensitivity during calibration.
Jan 12, 2005	Z-1406-06	—	terminated	QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.