PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 21, 2025 Initiated: April 28, 2025 #Z-1748-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Abbott Molecular, Inc.
Units Affected
1447 units
Distribution
Worldwide - US Nationwide distribution.
Location
Des Plaines, IL

Frequently Asked Questions

What product 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. Recalled by Abbott Molecular, Inc.. Units affected: 1447 units.
Why was this product recalled? ▼
There were reports of an increase in reactive negative controls and false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2025. Severity: Moderate. Recall number: Z-1748-2025.

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