Abbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral 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: FDA Class II medical device recall with a risk-of-harm hazard (false positive test results could lead to incorrect patient treatment decisions). No reported illnesses or injuries are stated in the source, but the risk of harm is inherent in diagnostic test inaccuracy.
Plain-English summary
Abbott Molecular, Inc. is recalling the Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription PCR test used to detect and differentiate RNA from SARS-CoV-2, influenza A virus, influenza B virus, and Respiratory Syncytial Virus (RSV). The kit is intended for use with anterior nasal or nasopharyngeal swab specimens collected by healthcare providers, or anterior nasal swab specimens self-collected at healthcare locations, from individuals suspected of respiratory viral infection.
The recall was initiated due to reports of an increase in reactive negative controls and false positive results. Approximately 656 units worldwide have been distributed, including nationwide distribution in the United States. The affected lot number is 409384 (UDI-DI: 00884929049390).
Affected healthcare facilities and laboratories using this kit should stop use and contact Abbott Molecular for further instructions regarding the recall.
The recalled product
- Product
- 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
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-positive-results
- test-accuracy-error
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: 00884929049390
- Lot Number: 409384
Distribution
Distributed nationwide across the United States.
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