Abbott Molecular recalls
21 official recalls and safety alerts involving Abbott Molecular since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott Molecular or the relevant agency.
- 2025-05-21
USAbbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR)…
There were reports of an increase in reactive negative controls and false positive results.
- 2025-04-30
- US
Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001,…
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…
- 2024-11-06
- US
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 09N15-091
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…
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA,…Official notice → - 2024-05-01
- US
Abbott Molecular, Inc. recalls 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…
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA,…Official notice → - 2024-03-06
- US
Abbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
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.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.Official notice → - 2023-12-06
- US
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 reverse…
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.
- 2023-04-12
- US
Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
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…
FDA · DeviceAbbott Molecular, Inc.US Distribution to state of: PA, a government account.Official notice → - 2023-02-01
- US
Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing,…
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…
- 2022-12-28
- US
Abbott Molecular, Inc. recalls 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.
- 2022-11-30
- US
Abbott Molecular, Inc. recalls 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…
- 2022-09-14
- US
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 Vitro Diagnostic…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA · DeviceAbbott Molecular, Inc.Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO,…Official notice → - 2022-08-24
- US
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Incorrect optical calibration
- 2022-04-13
- US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - 2022-03-09
- US
Abbott Molecular, Inc. recalls Alinity m Integrated Reaction Units (IRU)
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL,…Official notice → - 2022-01-12
- US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is an issue with the installation of updated camera firmware on the system.
FDA · DeviceAbbott Molecular, Inc.Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US distribution and the countries of Australia,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a potential for abnormal (non-sigmoidal) amplification curves.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2021-10-20
- US
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
There is a potential for false positive results.
FDA · DeviceAbbott Molecular, Inc.Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL,…Official notice → - 2021-10-06
- US
Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/…
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →