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Abbott Molecular

Last updated May 23, 2026

What Abbott Molecular makes

Abbott Molecular manufactures in vitro diagnostic (IVD) devices for nucleic acid hybridization detection, including probe-based assays, reagents, and controls. Their portfolio also includes automated and semi-automated tissue processors, test tube racks, specimen/reagent container carriers, and DAPI solutions, alongside laboratory instruments and associated software applications. Notable product lines include systems like the m2000 series and Vysis probes for molecular diagnostics.

The company’s devices span Class I, Class II, and Class III regulatory classifications, with some classified as not applicable (N) under relevant frameworks. These products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their regulatory authorisation in the United States. Abbott Molecular operates as a US-based manufacturer within this regulatory scope.

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 Abbott Molecular manufacture?

Abbott Molecular specialises in in vitro diagnostic (IVD) devices primarily focused on nucleic acid hybridization detection. This includes probe-based assays, reagents, and controls for molecular testing, as well as automated or semi-automated tissue processors, test tube racks, specimen/reagent carriers, and DAPI solutions. Their product line also covers laboratory instruments and associated software applications, such as the m2000 series and Vysis probes, which are used for molecular diagnostics in clinical settings.

Where is Abbott Molecular based, and how does this affect its regulatory scope?

Abbott Molecular is based in the United States, which means its devices are subject to FDA regulatory requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, indicating they have undergone the necessary authorisation processes for market distribution in the US. This regulatory listing helps ensure compliance with US medical device standards.

Which regulatory registries list Abbott Molecular’s devices?

Abbott Molecular’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices that have been authorised for sale in the United States, ensuring transparency and traceability for regulatory and clinical purposes.

How are Abbott Molecular’s devices classified under regulatory frameworks?

Abbott Molecular’s devices fall into multiple regulatory classifications, including Class I, Class II, and Class III, depending on their intended use and risk level. Class I devices generally pose the lowest risk, while Class III devices are typically high-risk and require stringent pre-market approval. Some devices may also be classified as not applicable (N) under certain regulatory frameworks, indicating they do not fit standard classification criteria. These classifications help determine the level of oversight and authorisation required for each product.

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

Information

Country: US
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Catalogue (538)

Page 1 of 11

Device	Model / Reference	Registries	Class	Status
Vysis	07J03-001	FDA UDI	Class I	Active
Vysis	01N12-010	FDA UDI	Class I	Active
Vysis	05J41-001	FDA UDI	Class I	Active
Vysis	05J03-028	FDA UDI	Class I	Active
Vysis	01N78-020	FDA UDI	Class I	Active
Vysis	05J39-005	FDA UDI	Class II	Active
RealTime	2N40-70	FDA UDI	Class II	Active
m2000	04J71-80	FDA UDI	Class I	Active
Vysis	08N65-020	FDA UDI	Class I	Active
RealTime	6L18-80	FDA UDI	Class II	Active
Vysis	05J38-050	FDA UDI	Class II	Active
Vysis	06J50-001	FDA UDI	Class I	Active
Vysis	05J03-021	FDA UDI	Class I	Active
Vysis	05J38-030	FDA UDI	Class II	Active
Vysis	06J29-010	FDA UDI	Class I	Active
Vysis	09N23-020	FDA UDI	Class I	Active
Vysis	06J36-021	FDA UDI	Class I	Active
Vysis	05J05-001	FDA UDI	Class I	Active
Alinity m	08N45-085	FDA UDI	Class II	Active
Alinity mp	09N65-004	FDA UDI	Class I	Active
Vysis	01N99-001	FDA UDI	Class I	Active
Vysis	05J04-030	FDA UDI	Class I	Active
Vysis	05J17-034	FDA UDI	Class I	Active
ViroSeq	4J94-92	FDA UDI	Class I	Active
Vp2000	02J11-062	FDA UDI	Class I	Active
Alinity m	09N43-085	FDA UDI	Class II	Active
Vysis	07J22-050	FDA UDI	Class I	Active
Alinity m	08N45-03C	FDA UDI	Class II	Active
Alinity m	09N65-050	FDA UDI	Class I	Active
Alinity m	09N26-019	FDA UDI	Class II	Active
Vysis	05J04-033	FDA UDI	Class I	Active
Vysis	06J96-001	FDA UDI	Class I	Active
Alinity m	09N79-05D	FDA UDI	N	Active
Vysis	08N85-005	FDA UDI	Class I	Active
Vysis	05J84-010	FDA UDI	Class I	Active
Vysis	05J48-013	FDA UDI	Class I	Active
UroVysion	02J27-095	FDA UDI	Class III	Active
Vysis	06J37-014	FDA UDI	Class I	Active
Vysis	02J10-032	FDA UDI	Class I	Active
Vp2000	02J11-065	FDA UDI	Class I	Active
Vysis	06J54-027	FDA UDI	Class I	Active
Vysis	05J10-051	FDA UDI	Class I	Active
Vysis	05J32-080	FDA UDI	Class I	Active
Vysis	08L79-020	FDA UDI	Class I	Active
Vysis	07J22-012	FDA UDI	Class I	Active
Vysis	05J15-011	FDA UDI	Class I	Active
Alinity m	09N17-085	FDA UDI	Class II	Active
Vysis	05J04-081	FDA UDI	Class I	Active
Vysis	05J85-001	FDA UDI	Class I	Active
RealTime	09N27-090	FDA UDI	N	Active

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FDA Recalls (47)

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

Abbott Molecular has 47 FDA recall records spanning from October 28, 2005, to April 28, 2025, with statuses including completed, open, classified, and terminated. The recalls involve issues such as thermal malfunctions in the VP 2000 Slide Processor, incorrect bar code configurations in user guides, probe contamination in DNA testing kits, software incompatibilities with the m2000sp system, overheating and fire risks in liquid waste sensors, and errors in test results or system alerts. Additional concerns include potential amplification curve abnormalities, misquantitation in sample readings, and software bugs affecting test order sorting on the m2000rt System.

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
Apr 28, 2025	Z-1748-2025	—	open, classified	There were reports of an increase in reactive negative controls and false positive results.
Apr 28, 2025	Z-1749-2025	—	open, classified	There were reports of an increase in reactive negative controls and false positive results.
Mar 20, 2025	Z-1665-2025	—	open, classified	The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Sep 12, 2024	Z-0233-2025	—	open, classified	Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Sep 12, 2024	Z-0234-2025	—	open, classified	Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Mar 20, 2024	Z-1602-2024	—	open, classified	The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
Feb 1, 2024	Z-1188-2024	—	open, classified	Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Feb 1, 2024	Z-1190-2024	—	open, classified	Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Feb 1, 2024	Z-1189-2024	—	open, classified	Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Oct 30, 2023	Z-0407-2024	—	open, classified	Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Dec 9, 2022	Z-1009-2023	—	open, classified	The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Nov 22, 2022	Z-0740-2023	—	open, classified	Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Nov 22, 2022	Z-0739-2023	—	open, classified	Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Nov 11, 2022	Z-1349-2023	—	open, classified	The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Oct 12, 2022	Z-0268-2023	—	open, classified	Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
Aug 19, 2022	Z-1679-2022	—	open, classified	Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Jul 19, 2022	Z-1518-2022	—	completed	Incorrect optical calibration
Mar 4, 2022	Z-0883-2022	—	open, classified	There is a potential for misquantitation high results of negative samples.
Mar 4, 2022	Z-0884-2022	—	open, classified	There is a potential for misquantitation high results for negative samples.
Feb 11, 2022	Z-0710-2022	—	terminated	There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Dec 6, 2021	Z-0462-2022	—	open, classified	There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Dec 6, 2021	Z-0463-2022	—	terminated	There is an issue with the installation of updated camera firmware on the system.
Dec 6, 2021	Z-0461-2022	—	open, classified	There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Dec 6, 2021	Z-0460-2022	—	open, classified	There is a potential for abnormal (non-sigmoidal) amplification curves.
Sep 2, 2021	Z-0007-2022	—	terminated	There is a potential for false positive results.
Sep 2, 2021	Z-0008-2022	—	terminated	There is a potential for false positive results.
Sep 2, 2021	Z-0006-2022	—	terminated	There is a potential for false positive results.
Sep 2, 2021	Z-0004-2022	—	terminated	There is a potential for false positive results.
Sep 2, 2021	Z-0005-2022	—	terminated	There is a potential for false positive results.
Aug 4, 2021	Z-2576-2021	—	terminated	Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Oct 23, 2014	Z-0463-2015	—	terminated	Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.
Jun 19, 2014	Z-2169-2014	—	terminated	Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
Nov 23, 2013	Z-0948-2015	—	terminated	The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
Mar 28, 2013	Z-1491-2014	—	terminated	20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.
Dec 4, 2012	Z-0634-2013	—	terminated	An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
Jan 31, 2012	Z-2013-2012	—	terminated	In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Ab
Oct 11, 2011	Z-0365-2012	—	terminated	Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
Sep 8, 2011	Z-0048-2012	—	terminated	The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the final results, which could cause an inval
Dec 20, 2010	Z-1397-2011	—	terminated	Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
Dec 20, 2010	Z-1399-2011	—	terminated	Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
Dec 20, 2010	Z-1398-2011	—	terminated	Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
Jul 20, 2010	Z-2313-2010	—	terminated	The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
Jan 22, 2010	Z-1147-2010	—	terminated	The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
Jan 22, 2010	Z-1148-2010	—	terminated	The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
Sep 15, 2008	Z-1929-2009	—	terminated	Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor.
Dec 22, 2006	Z-0595-2007	—	terminated	The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.
Oct 28, 2005	Z-0416-06	—	terminated	The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.