Recall Z-0342-2023— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-0342-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-19

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2022-10-19. It names one FDA 510(k) clearance: K982485. Product: CMV IgM EIA, in vitro diagnostic.. Reason: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA)..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-19
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K982485 — SERAQUEST CMV IGMQuest Intl., Inc.·cleared 1999-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CMV IgM EIA, in vitro diagnostic.

Reason for recall

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

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