Bio-Rad Laboratories: Medical Device Recall in 2024 - (Recall #: Z-1358-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 15, 2024

Date Posted: April 3, 2024

Recall Number: Z-1358-2024

Event ID: 94020

Reason for Recall:

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

Status: Ongoing

Product Quantity: 33 units

Code Information:

Lot # 64562656 & 64571846/ UDI: 03610521162834

Distribution Pattern:

US Nationwide distribution in the states of PA, SD, TX, FL, MN.

Voluntary or Mandated:

Voluntary: Firm initiated