FDA Medical devices recall ·
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096… recall
- Recall number
- Z-1749-2025
- 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
- 656 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
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: 00884929049390; Lot Number: 409384
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-1749-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.