Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) Recalled by Abbott Molecular, Inc. Due to There were reports of an increase in reactive...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Molecular, Inc. directly.
Affected Products
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
Quantity: 1447 units
Why Was This Recalled?
There were reports of an increase in reactive negative controls and false positive results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Molecular, Inc.
Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report