PlainRecalls

Abbott Molecular, Inc.

20 recalls on record · Latest: May 21, 2025

Abbott Molecular, Inc. Recall Insight

Abbott Molecular, Inc. appears on 20 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.024% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 21, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 20 entries, severity tagging shows 5 critical, 13 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 19 of 20 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (20). The date window on this page runs from Oct 6, 2021 to May 21, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 21, 2025

Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended …

FDA Devices Moderate May 21, 2025

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…

FDA Devices Moderate Apr 30, 2025

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and …

FDA Devices Moderate Nov 6, 2024

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

FDA Devices Moderate Nov 6, 2024

Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

FDA Devices Moderate May 1, 2024

Alinity m System, Part Number: 08N53-002

FDA Devices Low Mar 6, 2024

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

FDA Devices Low Mar 6, 2024

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Pro…

FDA Devices Moderate Apr 12, 2023

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

FDA Devices Moderate Dec 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

FDA Devices Moderate Nov 30, 2022

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

FDA Devices Moderate Apr 13, 2022

Alinity m HBV AMP Kit (US and CE)

FDA Devices Moderate Mar 9, 2022

Alinity m Integrated Reaction Units (IRU)

FDA Devices Moderate Jan 12, 2022

Alinity m System, Part No. 08N53-002

FDA Devices Critical Oct 20, 2021

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

FDA Devices Critical Oct 20, 2021

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

FDA Devices Critical Oct 20, 2021

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

FDA Devices Critical Oct 20, 2021

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

FDA Devices Critical Oct 20, 2021

Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

FDA Devices Moderate Oct 6, 2021

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, Spect…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds