Abbott Molecular, Inc.: Device Recall
Recall #Z-1748-2025 · 04/28/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1748-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Abbott Molecular, Inc.
- Status
- Ongoing
- Date Initiated
- 04/28/2025
- Location
- Des Plaines, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1447 units
Reason for Recall
There were reports of an increase in reactive negative controls and false positive results.
Product Description
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
Distribution Pattern
Worldwide - US Nationwide distribution.
Other Recalls by Abbott Molecular, Inc.
- Class II: Risk 04/28/2025
- Class II: Risk 03/20/2025
- Class II: Risk 09/12/2024
- Class II: Risk 09/12/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.