Recall Z-1096-2022— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-1096-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-14

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2022-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack. Reason: Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-14
Firm location: Redmond, WA, United States

Product description

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Reason for recall

Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

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