Class II — Potential Health Hazard

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

Bio-Rad Recalled by Bio-Rad Laboratories Due to Due to incorrect calibrations and controls, their is...

Date: February 15, 2024
Company: Bio-Rad Laboratories
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 directly.

Affected Products

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

Quantity: 33 units

Why Was This Recalled?

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bio-Rad Laboratories

Bio-Rad Laboratories has 3 total recalls tracked by RecallDetector.

Related Recalls

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