Recall Z-0463-2022— Abbott Molecular, Inc.

Name: FDA recall Z-0463-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-06

Class II · Terminated

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2021-12-06, terminated 2024-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity m System, Part No. 08N53-002. Reason: There is an issue with the installation of updated camera firmware on the system..

Recalling firm: Abbott Molecular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-06
Terminated: 2024-09-30
Firm location: Des Plaines, IL, United States

Product description

Alinity m System, Part No. 08N53-002

Reason for recall

There is an issue with the installation of updated camera firmware on the system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.