CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report

Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled

Bio-Rad Laboratories is recalling Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit, distributed nationwide in the US. The recall was initiated on 15 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 64562656 & 64571846/ UDI: 03610521162834
Quantity recalled33 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1358-2024
FDA event ID
94020
Recalling firm
Bio-Rad Laboratories, Pleasanton, CA
Classification
Class II
Status
Ongoing
Recall initiated
15 Feb 2024
FDA classified
22 Mar 2024
Reported
3 Apr 2024
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

15 Feb 2024Recall initiated by company
22 Mar 2024Classified by FDA+36 days
3 Apr 2024Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide FloridaMinnesotaPennsylvaniaSouth DakotaTexas

Questions about this recall

Is Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled?

Yes. Bio-Rad Laboratories recalled Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit on 15 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1358-2024.

Why was it recalled?

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

Which lots are affected?

Lot # 64562656 & 64571846/ UDI: 03610521162834

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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