Abbott Molecular
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000017776
Abbott Molecular is a medical device manufacturer based in the United States, with 732 devices listed in 4 registries (FDA Class I and II; EU Class A and C) and 47 FDA recalls as of 13 Nov 2026.
- Devices
- 732
- Registrations
- EUDAMED
- FDA recalls
- 4720 ongoing
Registry facts
- Registries
- FDA GUDID 516
- EUDAMED 254
- FDA 510(k) 17
- FDA PMA 14
- Device classes
- FDA Class I 346
- FDA Class II 158
- EU Class A 89
- EU Class C 69
- FDA Unclassified 23
- FDA Class III 20
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000017776
At a glance
EU certificates
4 of 4 in force.
Market reach
- European Union
- EUDAMED actor, 4 certificates
- United States
- FDA recalls
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.
Catalogue
Search and filter all 732 devicesShowing 1-50 of 732
Company details
- EUDAMED SRN
- US-MF-000017776
- EU VAT number
- 36-0698440
- EUDAMED status
- Active since 2025
- EUDAMED registered name
- Abbott Molecular Inc.
- Registered address
- 1300, East Touhy Avenue, 60018, Des Plaines, IL, United States
- PRRC contact
- Stacy Ferguson
EUDAMED certificates
4 certificates4 valid, 0 expiredIVDR 4next expiry 19 Jul 2028
BSI Group The Netherlands B.V. 2797 4 certificates
- IVDR 776722 Active
Technical documentation EU IVDR
- Issued
- 27 Aug 2025
- Expires
- 26 Aug 2030
- IVDR 798927 Active
Technical documentation EU IVDR
- Issued
- 19 Mar 2025
- Expires
- 15 Jul 2029
- Valid from
- 1 May 2025
- Reason
- Other
- IVDR 798928 Active
Technical documentation EU IVDR
- Issued
- 19 Mar 2025
- Expires
- 15 Jul 2029
- Valid from
- 7 Apr 2025
- Reason
- Other
- IVDR 747615 Active
Quality management system EU IVDR
- Issued
- 23 Jul 2026
- Expires
- 19 Jul 2028
- Reason
- Add device or group
FDA recalls
FDA recall records list 47 recalls initiated by Abbott Molecular, the earliest on 2005-10-28 and the most recent on 2025-04-28. By recorded status: 20 ongoing, 26 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, 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.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 10
- 2022 10
- 2023 1
- 2024 6
- 2025 3
- 2026 0
2025
- 28 Apr 2025 Z-1748-2025 Class II Ongoing There were reports of an increase in reactive negative controls and false positive results.
- 28 Apr 2025 Z-1749-2025 Class II Ongoing There were reports of an increase in reactive negative controls and false positive results.
- 20 Mar 2025 Z-1665-2025 Class II Ongoing 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.
2024
- 12 Sep 2024 Z-0233-2025 Class II Ongoing 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.
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- 12 Sep 2024 Z-0234-2025 Class II Ongoing 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.
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- 20 Mar 2024 Z-1602-2024 Class II Ongoing 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.
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- 1 Feb 2024 Z-1188-2024 Class III Ongoing 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.
- 1 Feb 2024 Z-1189-2024 Class III Ongoing 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.
- 1 Feb 2024 Z-1190-2024 Class III Ongoing 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.
- 12 Sep 2024 Z-0233-2025 Class II Ongoing 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.
2023
- 30 Oct 2023 Z-0407-2024 Class II Ongoing 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.
Show the 25 most recent of 47 recalls
2022
- 9 Dec 2022 Z-1009-2023 Class II Ongoing 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.
- 22 Nov 2022 Z-0739-2023 Class II Ongoing Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- 22 Nov 2022 Z-0740-2023 Class II Ongoing Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- 11 Nov 2022 Z-1349-2023 Class II Ongoing 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.
- 12 Oct 2022 Z-0268-2023 Class II Ongoing 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.
- 19 Aug 2022 Z-1679-2022 Class II Ongoing Reports received of an increase of message code 9186 (internal control failed) when using the kit.
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- 19 Jul 2022 Z-1518-2022 Class II Completed Incorrect optical calibration
- 4 Mar 2022 Z-0883-2022 Class II Ongoing There is a potential for misquantitation high results of negative samples.
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- 4 Mar 2022 Z-0884-2022 Class II Ongoing There is a potential for misquantitation high results for negative samples.
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- 11 Feb 2022 Z-0710-2022 Class II Terminated There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
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2021
- 6 Dec 2021 Z-0460-2022 Class II Ongoing There is a potential for abnormal (non-sigmoidal) amplification curves.
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- 6 Dec 2021 Z-0461-2022 Class II Ongoing There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
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- 6 Dec 2021 Z-0462-2022 Class II Terminated There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
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- 6 Dec 2021 Z-0463-2022 Class II Terminated There is an issue with the installation of updated camera firmware on the system.
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- 2 Sep 2021 Z-0004-2022 Class I Terminated There is a potential for false positive results.
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- 6 Dec 2021 Z-0460-2022 Class II Ongoing There is a potential for abnormal (non-sigmoidal) amplification curves.
Frequently asked questions
How many devices does Abbott Molecular have in the registry?
The registry currently lists 732 devices for Abbott Molecular. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Molecular's devices?
Among its 50 most recently registered devices, Abbott Molecular has devices listed in EUDAMED (50 devices).
What risk classes do Abbott Molecular's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Abbott Molecular's devices are IVDR Class A, IVDR Class C, IVDR Class D and IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Molecular?
FDA recall records list 47 recalls initiated by Abbott Molecular, the most recent initiated on 28 Apr 2025. 20 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Abbott Molecular?
EUDAMED lists 4 certificates for Abbott Molecular (technical documentation; quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 23 Jul 2026.
What are the newest devices from Abbott Molecular in the registry?
The most recently registered devices listed for Abbott Molecular include UroVysion, Vysis, VP2000 and PathVysion.