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Open, Classified

CMV IgM EIA, in vitro diagnostic.

FDA Recall Z-0342-2023 · Posted 2022-12-06

Recalling FirmBio-Rad Laboratories, Inc.
Recall StatusOpen, Classified
Product CodeLFZ
Date Initiated2022-10-19
Product Quantity180 kits

Reason for Recall

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

Firm Action

On or about 10/19/2022, the firm sent an "URGENT: Medical Device Recall" letter via UPS overnight to customers to inform them, Bio-Rad has received complaints of an unusual increase in the positivity rate with the Bio-Rad CMV IgM EIA kits. Customers are instructed to discontinue use and to dispose of any unused product of Batch NumbersB02022, E10022, and G05022 of the Bio-Rad CMV IgM EIA (Material No. 25178; GTIN/UDI 00847865010733) according to local waste management procedures. If you have further distributed or transferred the product to other Bio-Rad customers, or labs from your site, please be sure to notify those customers of this field action. For any questions regarding this information, please contact Bio-Rad Laboratories Technical Support at 1-800-2BIORAD (1-800-224-6723), option #2, and then option #3, or by emailing [email protected] for further assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982485SERAQUEST CMV IGMQuest Intl., Inc. · 1999-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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