Recall Z-0462-2022— Abbott Molecular, Inc.

Name: FDA recall Z-0462-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-06

Class II · Ongoing

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2021-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity m System, Part No. 08N53-002. Reason: There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high..

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

Product description

Alinity m System, Part No. 08N53-002

Reason for recall

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

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