medical Class II Updated 2025-05-21

Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a mult

Recalled 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 (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.


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: 00884929049390; Lot Number: 409384
View official government recall

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