Sendx Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Sendx Medical, Inc. makes
Sendx Medical, Inc. manufactures blood gas and electrolyte analysis systems, including the ABL 80 CO-OX SYSTEM, ABL80 FLEX and ABL80 FLEX CO-OX, ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM, ABL80 FLEX ANALYZER, ABL80 FLEX CO-OX with AQURE connectivity, and SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Abl 80 Co-Ox System Ref K080370
Regimes: 510(k) Registry: 510(k)ABL80 FLEX and ABL80 FLEX CO-OX Ref K151639
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
ABL80 Flex Analyzer Ref K051804
Regimes: 510(k) Registry: 510(k)ABL80 FLEX CO-OX with AQURE connectivity Ref K151856
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by Sendx Medical, Inc., the earliest on 2007-03-27 and the most recent on 2012-06-06. By recorded status: 7 terminated. The reasons filed fall into these groups: software or firmware, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 6 Jun 2012 Z-2304-2012 Class II Terminated The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
- 30 Jan 2012 Z-1384-2012 Not yet classified Terminated The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
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2010
- 6 Jan 2010 Z-0195-2013 Class II Terminated The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
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- 6 Jan 2010 Z-0195-2013 Class II Terminated The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
2009
- 20 Feb 2009 Z-0150-2010 Unclassified (pre-2012) Terminated Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the
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- 20 Feb 2009 Z-0150-2010 Unclassified (pre-2012) Terminated Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the
2007
- 19 Jun 2007 Z-1173-2007 Unclassified (pre-2012) Terminated Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.
- 4 Jun 2007 Z-1201-2007 Unclassified (pre-2012) Terminated The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err
- 27 Mar 2007 Z-1196-2007 Unclassified (pre-2012) Terminated There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.
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Frequently asked questions
How many devices does Sendx Medical, Inc. have in the registry?
The registry currently lists 6 devices for Sendx Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sendx Medical, Inc.'s devices?
Among its 6 most recently registered devices, Sendx Medical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Sendx Medical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sendx Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sendx Medical, Inc.?
FDA recall records list 7 recalls initiated by Sendx Medical, Inc., the most recent initiated on 6 Jun 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sendx Medical, Inc. in the registry?
The most recently registered devices listed for Sendx Medical, Inc. include ABL 80 CO-OX SYSTEM, ABL80 FLEX and ABL80 FLEX CO-OX, ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM and ABL80 FLEX ANALYZER.