Recall Z-1679-2022— Abbott Molecular, Inc.

Name: FDA recall Z-1679-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Class II · Ongoing

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-08-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.. Reason: Reports received of an increase of message code 9186 (internal control failed) when using the kit..

Recalling firm: Abbott Molecular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-19
Firm location: Des Plaines, IL, United States

Product description

Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

Reason for recall

Reports received of an increase of message code 9186 (internal control failed) when using the kit.

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