PlainRecalls

Abbott Molecular, Inc.

Compiled from official public sources by the publisher.

30 recalls on record · Latest: May 21, 2025

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Agency notice ledger

Federal filing book Abbott Molecular, Inc. MID-BOOK · SINGLE-AGENCY

#551 of 14,151 · 30 notices · 0.029% archive

  • BOOK 30 notices
  • RANK #551 of 14,151
  • SHARE 0.029% archive
  • AGENCY FDA Devices (30)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 21, 2025
  • PHOTO Applied Medical Resou…

Nearest notice-volume peer: Applied Medical Resources Corp (0 notice gap)

Abbott Molecular, Inc. accounts for about 0.029% of the 104,423-notice archive on 30 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Abbott Molecular, Inc.'s standing among 14,151 recalling firms

Abbott Molecular, Inc. ranks 551st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abbott Molecular, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

30 551st of 14151 higher than 13,589 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Abbott Molecular, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abbott Molecular, Inc. holds about 0.029% of archive notices alongside 30 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare

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 (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
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 08N53-032 (Refurbished).
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 Probe, REF 01N34-020;
FDA Devices Low Mar 6, 2024

In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
FDA Devices Moderate Dec 6, 2023

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 transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
FDA Devices Moderate Apr 12, 2023

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
FDA Devices Moderate Feb 1, 2023

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
FDA Devices Moderate Dec 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
FDA Devices Moderate Dec 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
FDA Devices Moderate Nov 30, 2022

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Devices Moderate Sep 14, 2022

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 Use.
FDA Devices Moderate Aug 24, 2022

The 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 Apr 13, 2022

Alinity m HBV Application Specification File (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 Moderate Jan 12, 2022

Alinity m System, Part No. 08N53-002
FDA Devices Moderate Jan 12, 2022

Alinity m System, Part No. 08N53-002
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, SpectrumAqua/CEP 12 SpectrumGreen Probes

Abbott Molecular, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Applied Medical Resources Corp 30 Biomet Uk Ltd. 30 Sklar Instruments 30 Trumpf Medical Systems, Inc. 30

Frequently Asked Questions

How many federal recall notices name Abbott Molecular, Inc.? ▼
PlainRecalls indexes 30 distinct federal recall events naming Abbott Molecular, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Abbott Molecular, Inc. sit among other recalling firms? ▼
Abbott Molecular, Inc. ranks #551 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abbott Molecular, Inc.'s notices? ▼
FDA Devices accounts for 30 of this firm's 30 indexed notices.
What product category dominates Abbott Molecular, Inc.'s filing book? ▼
Filings for Abbott Molecular, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Abbott Molecular, Inc.: 30 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Abbott Molecular, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026