Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription…

Recall date

April 28, 2025

Source

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

Recall number

Z-1748-2025

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 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