Bio-Rad Laboratories, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0342-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CMV IgM EIA, in vitro diagnostic.

Product Classification:

Class II

Date Initiated: October 19, 2022

Date Posted: December 7, 2022

Recall Number: Z-0342-2023

Event ID: 91106

Reason for Recall:

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

Status: Ongoing

Product Quantity: 180 kits

Code Information:

Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

Distribution Pattern:

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated