Device 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
Z-1748-2025
Product summary
- Event
- Event 96790
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1447 units
- Official record key
device-enforcement:Z-1748-2025
Official wording
Reason: There were reports of an increase in reactive negative controls and false positive results.
Code information: UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
There were reports of an increase in reactive negative controls and false positive results.