Abbott Molecular, Inc.: Device Recall

Recall Details

Recall Number

Z-1749-2025

Classification

Class II

Product Type

Device

Recalling Firm

Abbott Molecular, Inc.

Status

Ongoing

Date Initiated

04/28/2025

Location

Des Plaines, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

656 units

Reason for Recall

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

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.

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Abbott Molecular, Inc.

• Class II: Risk 04/28/2025
  There were reports of an increase in reactive negative controls and false positive results.
• Class II: Risk 03/20/2025
  The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
• Class II: Risk 09/12/2024
  Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
• Class II: Risk 09/12/2024
  Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

View all recalls by Abbott Molecular, Inc. →