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