Recall Z-1518-2022— Abbott Molecular, Inc.

Name: FDA recall Z-1518-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-19

Class II · Completed

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.. Reason: Incorrect optical calibration.

Recalling firm: Abbott Molecular, Inc.
Classification: Class II
Status: Completed
Initiated: 2022-07-19
Firm location: Des Plaines, IL, United States

Product description

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Reason for recall

Incorrect optical calibration

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