Home / Recalls / Bio-Rad Laboratories / Z-1358-2024

Z-1358-2024 Class II Ongoing

Recalled by Bio-Rad Laboratories — Pleasanton, CA

Recall Details

Product Type
Devices
Report Date
April 3, 2024
Initiation Date
February 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot # 64562656 & 64571846/ UDI: 03610521162834

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