Every recall we track for Abbott Molecular, Inc. — 30 in all — plus the complaints and injury reports the public filed about them.
Abbott recalls Alinity m Resp-4-Plex Amplification Kit (CE) due to reported false positive results in respiratory virus tests. Affected kits may cause inaccurate test outcomes.
Abbott recalls Alinity m Resp-4-Plex AMP Kit (List 09N7:096) due to reported false positive results in COVID-19 testing. Affected units may produce inaccurate test outcomes.
Abbott recalls Alinity m System models 08N53-001, 08N53-002, and 08N53-032 (refurbished) due to liquid waste potentially flowing into walking paths. All units with these serial numbers are affected.
Abbott recalls Alinity m STI AMP Kit (product codes REF 09N17-095, 09N17-090, 09N17-091) due to potential iron leaching causing Error Code 9198. Affected units may need replacement.
Abbott recalls Alinity m HPV AMP Kit (product codes REF 09N15-095, 09N15-090, 09N15-091) due to potential false negative results from iron leaching in the lysis solution.
Abbott recalls Alinity m System (part 08N53-002) due to error message when using Copan UTM-RT tubes, which may cause incorrect test results.
Abbott recalls five in-vitro diagnostic kits shipped to U.S. customers without U.S. approval or registration. Products intended for export only were mistakenly shipped to U.S. customers.
Abbott recalls two in-vitro diagnostic kits shipped to U.S. customers without U.S. approval. Products intended for export were mistakenly sent to U.S. markets, posing no immediate safety risk but requiring return.
Abbott Molecular recalls M1000 Wash Station Assembly & DITI Slide (REF 04J72-28) shipped to U.S. customers without U.S. approval. This export-only product may not meet U.S. specifications.
Abbott recalls Alinity m HCV AMP kits with specific lot numbers due to increased false positives in hepatitis C testing. Affected kits may produce inaccurate results, requiring replacement.
Abbott recalls Alinity m System devices with potential calibration errors that could misconfigure testing results. Affected units may need recalibration or correction.
Abbott recalls Alinity m Resp-4-Plex Amp Kit (lot numbers 381177, 525460, etc.) due to reports of false positive results. Consumers should check their kit's lot number and contact Abbott for guidance.
Abbott recalls specific lots of Alinity m Resp-4-Plex Amp Kit due to increased false positive results. Affected units may cause inaccurate test results.
Abbott recalls Alinity m System with specific serial numbers due to potential for incorrect results after calibration. Affected units may need recalibration to ensure accurate test results.
Abbott recalls Alinity m System software version 1.6.5 for potential test errors. Affected units may have waste chute issues, barcode misreads, or calibration problems. Contact Abbott for details.
Abbott recalls Alinity m SARS-CoV-2 Control Kits (REF 09N78-085) due to reported message code 9186 errors. Affected kits may show internal control failures during testing.
Abbott recalls Alinity m System (REF 08N53-002) for incorrect optical calibration that may affect diagnostic accuracy. No immediate action needed but check for serial number 00654.
Abbott recalls Alinity m HBV Application Specification Files for potential misquantitation of negative samples. Affected versions include US 08N47-03A (v1.00) and CE 08N47-01B (v2.00), 08N47-01C (v3.00).
Abbott recalls Alinity m HBV AMP Kit (US and CE) due to potential misquantitation causing high results for negative samples. Affected lots listed in the recall notice.
Abbott recalls Alinity m Integrated Reaction Units with potential for Reaction Vessels to detach from caps during pipettor robot transport. Affected units have specific lot numbers. Consumers should contact Abbott for details.
Abbott Molecular recalls Alinity m System with Part No. 08N53-002 due to potential camera firmware installation issues. 74 impacted units identified.
Abbott recalls Alinity m System with part number 08N53-002 due to a software defect that may cause incorrect settings in the Amplification Detection clamp. Affected units include all serial numbers of this model.
Abbott recalls Alinity m System model 08N53-002 due to software issues affecting field service maintenance procedures. Affected units may require specific software updates to prevent improper maintenance.
Abbott Molecular recalls Alinity m System (Part No. 08N53-002) due to potential for abnormal amplification curves. Affected units may produce inaccurate test results.
Abbott recalls Alinity m Resp-4-Plex AMP Kit and Application for potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should contact Abbott for details.
Abbott recalls Alinity m SARS-CoV-2 test kits (Non-US Assay) due to potential false positive results. Affected kits have specific lot numbers and expiration dates listed in the recall notice.
Abbott recalls Alinity m SARS-CoV-2 test kits that may produce false positive results. Affected kits have specific lot numbers and expiration dates. Consumers should check their kit's serial number and expiration date.
Abbott recalls Alinity m Resp-4-Plex AMP Kit (Non-US Assay) due to potential for false positive results in in vitro diagnostic testing. Affected units include specific lot numbers from 2021-2023.
Abbott recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) due to potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should check their kit details.
Abbott recalls Vysis CLL FISH Probe Kits that may not detect 13q deletions in cancer samples. Affected kits have specific part numbers and lot codes. Contact Abbott for details.
