PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 21, 2025 Initiated: April 28, 2025 #Z-1749-2025

Product Description

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.

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
656 units
Distribution
Worldwide - US Nationwide distribution.
Location
Des Plaines, IL

Frequently Asked Questions

What product 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.. Recalled by Abbott Molecular, Inc.. Units affected: 656 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-1749-2025.

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