Home / Recalls / Bio-Rad Laboratories, Inc. / Z-0342-2023

Z-0342-2023 Class II Ongoing

Recalled by Bio-Rad Laboratories, Inc. — Redmond, WA

Recall Details

Product Type
Devices
Report Date
December 7, 2022
Initiation Date
October 19, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 kits

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).

Distribution Pattern

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

Code Information

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

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