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 Alinity m Resp-4-Plex AMP Kit Recall: False Positive Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52370-abbott-alinity-m-resp-4-plex-amp-kit-recall-false. Based on FDA recall #Z-1749-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1749-2025%22&limit=1).
The FDA announced on April 28, 2025, that Abbott Molecular, Inc. is recalling the Alinity m Resp-4-Plex AMP Kit due to reports of reactive negative controls and false positive results. The voluntary Class II recall affects 656 units distributed worldwide.
How to tell if you have it
Brand: Abbott
Product: Alinity m Resp-4-Plex AMP Kit
List Number: 09N79-096
Lot Number: 409384
UDI-DI: 00884929049390
The hazard
The recall cites reports of an increase in reactive negative controls and false positive results. The Alinity m Resp-4-Plex AMP Kit is 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, influenza B virus, and/or Respiratory Syncytial Virus.
Context
GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since August 4, 2021. Recent similar recalls include the Abbott Alinity m System Recall regarding a liquid spill hazard on March 20, 2025, and the Abbott Alinity m STI AMP Kit Recall involving Error Code 9198 on September 12, 2024. Other recent recalls of similar products include the Abbott ID NOW Influenza A & B 2 Kit recall for higher invalid rates risk (February 9, 2026), the Biomerieux VITEK 2 AST-N461 Test Kit Recall for false resistant results risk (July 24, 2026), and the Meridian Bioscience Revogene C. difficile Test Recall for false-negative risk (December 5, 2025).
How to tell if you have this one
Check for the product name 'Alinity m Resp-4-Plex AMP Kit' with List Number 09N79-096. The kit was sold with Lot Number 409384.
Brand
Abbott
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-1748-2025
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; UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921
1447 units
Z-1749-2025
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 location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.; UDI-DI: 00884929049390; Lot Number: 409384
656 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the List Number 09N79-096 and Lot Number 409384 on the kit's label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1749-2025 (April 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1749-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.