FDA Medical devices recall ·
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090… recall
- Recall number
- Z-1748-2025
- Date
- (initiated April 28, 2025)
- Company / brand
- Abbott Molecular, Inc.
1300 E Touhy Ave, Des Plaines, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1447 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
There were reports of an increase in reactive negative controls and false positive results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1748-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.