Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain

Recalled May 21, 2025 · FDA recall Z-1749-2025 · Abbott Molecular

Hazard

There were reports of an increase in reactive negative controls and false positive results. · FDA Class II

Units

656 units

Sold at

Worldwide - US Nationwide distribution.

Description

There were reports of an increase in reactive negative controls and false positive results.

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.

Manufacturer(s)

Abbott Molecular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →