Recall Z-1749-2025— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2025-04-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There were reports of an increase in reactive negative controls and false positive results..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-28
- Firm location
- Des Plaines, IL, United States
Product description
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.
Reason for recall
There were reports of an increase in reactive negative controls and false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.