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Abbott Molecular Recalls
36 recalls on record · July 25, 2012 to May 21, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 21, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain
Hazard: There were reports of an increase in reactive negative controls and false positive results.
May 21, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (
Hazard: There were reports of an increase in reactive negative controls and false positive results.
April 30, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a
Hazard: 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.
November 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF
Hazard: 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.
November 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF
Hazard: 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.
May 1, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part Number: 08N53-002
Hazard: 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.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Hazard: 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.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT
Hazard: 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.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319
Hazard: 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.
December 6, 2023Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro revers
Hazard: 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.
April 12, 2023Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Hazard: 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.
February 1, 2023Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes s
Hazard: 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.
December 28, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Hazard: Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
December 28, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Hazard: Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
November 30, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Hazard: 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.
September 14, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In
Hazard: Reports received of an increase of message code 9186 (internal control failed) when using the kit.
August 24, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Hazard: Incorrect optical calibration
April 13, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
Hazard: There is a potential for misquantitation high results for negative samples.
April 13, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
Hazard: There is a potential for misquantitation high results of negative samples.
March 9, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Integrated Reaction Units (IRU)
Hazard: There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
January 12, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Hazard: There is an issue with the installation of updated camera firmware on the system.
January 12, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Hazard: There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
January 12, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Hazard: There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
January 12, 2022Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Hazard: There is a potential for abnormal (non-sigmoidal) amplification curves.
October 20, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnost
Hazard: There is a potential for false positive results.
October 20, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Hazard: There is a potential for false positive results.
October 20, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Hazard: There is a potential for false positive results.
October 20, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specificatio
Hazard: There is a potential for false positive results.
October 20, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification
Hazard: There is a potential for false positive results.
October 6, 2021Medical DevicesFDA
Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319,
Hazard: Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.