Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CMV IgM EIA Recalled by Bio-Rad Laboratories, Inc. Due to Due to an unusual increase in the positivity...

Date: October 19, 2022
Company: Bio-Rad Laboratories, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Rad Laboratories, Inc. directly.

Affected Products

CMV IgM EIA, in vitro diagnostic.

Quantity: 180 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 14 states: CA, CO, FL, GA, HI, IA, MA, MN, NH, NJ, NC, PA, TN, TX

Affected (14 states)Not affected

About Bio-Rad Laboratories, Inc.

Bio-Rad Laboratories, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report