Device 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.
Z-1749-2025
Product summary
- Event
- Event 96790
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 656 units
- Official record key
device-enforcement:Z-1749-2025
Official wording
Reason: There were reports of an increase in reactive negative controls and false positive results.
Code information: UDI-DI: 00884929049390; Lot Number: 409384
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
There were reports of an increase in reactive negative controls and false positive results.