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

Recall date

April 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1749-2025

FDA classification

Class II

Brand / firm

Abbott Molecular, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.