Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Num
Recalled 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 (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
Hazard / Issue
There were reports of an increase in reactive negative controls and false positive results.
Issued by
FDA
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