FDA Device recall Z-1748-2025
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chai…
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chai… by Abbott Molecular, citing there were reports of an increase in reactive negative controls and false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1748-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-28 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Molecular |
| Distribution | US |
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
Reason
There were reports of an increase in reactive negative controls and false positive results.
Identifiers
| code_info | UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1748-2025%22
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