Medical Device Recall: 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
Abbott Molecular, Inc. · April 28, 2025
Reason for Recall
There were reports of an increase in reactive negative controls and false positive results.
Product Description
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
Distribution
Worldwide - US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
1447 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1748-2025
Status: ongoing
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