Abbott Molecular, Inc. Recalls

All product recalls associated with Abbott Molecular, Inc..

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Recall Summary

Total Recalls

17

Past Year

3

Class I (Serious)

0

Most Recent

Apr 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–17 of 17 recalls

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

There were reports of an increase in reactive negative controls and false positive results.

Moderate

FDAApr 28, 2025Nationwide• Abbott Molecular, Inc.

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

There were reports of an increase in reactive negative controls and false positive results.

Moderate

FDAApr 28, 2025Nationwide• Abbott Molecular, Inc.

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

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.

Moderate

FDA

Mar 20, 2025

Nationwide

• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m HPV AMP Kit, used with the Alinity m Sys...

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.

Moderate

FDASep 12, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m STI AMP Kit, used with the Alinity m Sys...

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.

Moderate

FDASep 12, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m System, Part Number: 08N53-002

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.

Moderate

FDAMar 20, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12...

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.

Moderate

FDAFeb 1, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Wash station: M1000 Wash Station Assembly & DITI Slide, ...

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.

Moderate

FDAFeb 1, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 ...

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.

Moderate

FDAOct 30, 2023Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m System. The Alinity m System is designed to ...

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.

Moderate

FDADec 9, 2022Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Moderate

FDANov 22, 2022Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m System, REF 08N53-002, containing Amplif...

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.

Moderate

FDANov 11, 2022PA• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

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.

Moderate

FDAOct 12, 2022Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each...

Reports received of an increase of message code 9186 (internal control failed) when using the kit.

Moderate

FDAAug 19, 2022AZ, CA, CT +21 more• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m HBV Application Specification File (US and CE)

There is a potential for misquantitation high results of negative samples.

Moderate

FDAMar 4, 2022AZ, CA, IL +11 more• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m HBV AMP Kit (US and CE)

There is a potential for misquantitation high results for negative samples.

Moderate

FDAMar 4, 2022AZ, CA, IL +11 more• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Alinity m System, Part No. 08N53-002

There is a potential for abnormal (non-sigmoidal) amplification curves.

Moderate

FDADec 6, 2021Nationwide• Abbott Molecular, Inc.

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Abbott Molecular, Inc. Recalls

Recall Summary

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

Abbott Molecular, Inc.: Abbott Alinity m HPV AMP Kit, used with the Alinity m Sys...

Abbott Molecular, Inc.: Abbott Alinity m STI AMP Kit, used with the Alinity m Sys...

Abbott Molecular, Inc.: Alinity m System, Part Number: 08N53-002

Abbott Molecular, Inc.: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12...

Abbott Molecular, Inc.: Wash station: M1000 Wash Station Assembly & DITI Slide, ...

Abbott Molecular, Inc.: Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 ...

Abbott Molecular, Inc.: Alinity m System. The Alinity m System is designed to ...

Abbott Molecular, Inc.: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Abbott Molecular, Inc.: Abbott Alinity m System, REF 08N53-002, containing Amplif...

Abbott Molecular, Inc.: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Abbott Molecular, Inc.: Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each...

Abbott Molecular, Inc.: Alinity m HBV Application Specification File (US and CE)

Abbott Molecular, Inc.: Alinity m HBV AMP Kit (US and CE)

Abbott Molecular, Inc.: Alinity m System, Part No. 08N53-002