Class II — Potential Health Hazard

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

BioPlex 2200 REF 665-2050 Recalled by Bio-Rad Laboratories, Inc. Due to APLS IgM reagent kits were packaged with the...

Date: February 28, 2023
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

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Quantity: 932 Reagent Packs

Why Was This Recalled?

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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