← Every firm
Abbott Molecular, Inc. FDA Recalls
30 recalls on file across devices, 5 of them Class I and 20 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (Class IIApr 28, 2025There were reports of an increase in reactive negative contr |
| Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain Class IIApr 28, 2025There were reports of an increase in reactive negative contr |
| The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall aClass IIMar 20, 2025The design of the Alinity m System Solutions drawer enclosur |
| Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF Class IISep 12, 2024Abbott has identified an increase of incidences regarding Er |
| Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REFClass IISep 12, 2024Abbott has identified an increase of incidences regarding Er |
| Alinity m System, Part Number: 08N53-002Class IIMar 20, 2024The Alinity m System camera detects whether tubes are "cappe |
| In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTClass IIIFeb 1, 2024Products that were intended for export only which were not a |
| Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)Class IIIFeb 1, 2024Products that were intended for export only which were not a |
| In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319Class IIIFeb 1, 2024Products that were intended for export only which were not a |
| Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reversClass IIOct 30, 2023Abbott has received reports of an increase in reactive negat |
| Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sClass IIDec 9, 2022The firm identified the following three potential issues whi |
| Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096Class IINov 22, 2022Reports of an increase in reactive negative controls and fal |
| Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090Class IINov 22, 2022Reports of an increase in reactive negative controls and fal |
| Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.Class IINov 11, 2022The instrument was found to be installed without plunger ass |
| Alinity m System, REF 08N53-002, For In Vitro Diagnostic UseClass IIOct 12, 2022Abbott has identified potential performance issues for the A |
| 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 Class IIAug 19, 2022Reports received of an increase of message code 9186 (intern |
| The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.Class IIJul 19, 2022Incorrect optical calibration |
| Alinity m HBV Application Specification File (US and CE)Class IIMar 4, 2022There is a potential for misquantitation high results of neg |
| Alinity m HBV AMP Kit (US and CE)Class IIMar 4, 2022There is a potential for misquantitation high results for ne |
| Alinity m Integrated Reaction Units (IRU)Class IIFeb 11, 2022There is potential for the Reaction Vessels (RVs) detaching |
| Alinity m System, Part No. 08N53-002Class IIDec 6, 2021There is a software defect that can cause the Amplification |
| Alinity m System, Part No. 08N53-002Class IIDec 6, 2021There is a software issue associated with the ability to pro |
| Alinity m System, Part No. 08N53-002Class IIDec 6, 2021There is an issue with the installation of updated camera fi |
| Alinity m System, Part No. 08N53-002Class IIDec 6, 2021There is a potential for abnormal (non-sigmoidal) amplificat |
| Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification Class ISep 2, 2021There is a potential for false positive results. |
| Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnosticClass ISep 2, 2021There is a potential for false positive results. |
| Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostClass ISep 2, 2021There is a potential for false positive results. |
| Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnosticClass ISep 2, 2021There is a potential for false positive results. |
| Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application SpecificatioClass ISep 2, 2021There is a potential for false positive results. |
| Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319,Class IIAug 4, 2021Potential for Vysis CLL FISH Probe Kits not detecting 13q de |