The Recall Desk
HighFDA (Devices)·Z-1748-2025·Announced 2025-05-21

Abbott Alinity m Resp-4-Plex Amplification Kit Recall

Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic medical device with potential for significant harm: false positive results in respiratory virus testing could lead to inappropriate clinical decisions. The source text does not report actual illnesses or injuries, but the risk to patient care from test inaccuracy warrants a High severity rating.

Plain-English summary

Abbott Molecular, Inc. is recalling the Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090. This is a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test used to detect and differentiate RNA from influenza A virus, influenza B virus, Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal swab specimens from individuals showing signs and symptoms of respiratory tract infection.

The recall was initiated due to reports of an increase in reactive negative controls and false positive results.

The affected product has been distributed nationwide and worldwide. The recalled device includes lot numbers 409383, 410627, and 411921 (UDI-DI: 00884999049338). Healthcare providers and laboratories using this kit should contact Abbott Molecular for instructions on how to proceed, and should review any test results obtained using the affected lot numbers.

The recalled product

Product
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 (fl
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — Diagnostic Test / In Vitro
Hazard
  • false-positive-results
  • test-accuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 00884999049338
  • Lot Numbers: 409383 410627 411921

Distribution

Distributed nationwide across the United States.

Related recalls

Same category