Recall – Software issue prevents maintenance procedure

Company: Abbott Molecular, Inc.
Date of Enforcement Report: 12/12/2021
Class II

PRODUCT

Alinity m System, Part No. 08N53-002

Recall Number: Z-0461-2022

REASON

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

RECALLING FIRM/MANUFACTURER

Abbott Molecular, Inc. on 12/6/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

742 devices

DISTRIBUTION

U.S. Nationwide and International

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.