Abbott Molecular, Inc.: Device Recall

Recall Details

Recall Number

Z-1665-2025

Classification

Class II

Product Type

Device

Recalling Firm

Abbott Molecular, Inc.

Status

Ongoing

Date Initiated

03/20/2025

Location

Des Plaines, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

N/A

Reason for Recall

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.

Product Description

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

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 04/28/2025
  There were reports of an increase in reactive negative controls and false positive results.
• 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. →