Z-1748-2025 Class II Ongoing
FDA device recall Z-1748-2025 was initiated by Abbott Molecular, Inc. on April 28, 2025 and is designated Class II. Reason for recall: There were reports of an increase in reactive negative controls and false positive results. The recall status is ongoing. Affected quantity: 1447 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1447 units
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
Reason for Recall
There were reports of an increase in reactive negative controls and false positive results.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921