medical Class II Updated 2025-05-21

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921
View official government recall

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