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

Recalled May 21, 2025 · FDA recall Z-1748-2025 · Abbott Molecular

Hazard

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

Units

1447 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 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

Manufacturer(s)

Abbott Molecular, Inc.

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