Z-1358-2024Class II

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

Name: Z-1358-2024 Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Creator: Bio-Rad Laboratories
Published: 2024-02-15
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2024-02-15 / Open, Classified / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit on 2024-02-15. FDA classified it as Class II and gives the reason as "Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1358-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-15
Posted: 2024-03-22
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Product code: OYX Bcr/Abl1 Monitoring Test
Reason for recall: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 7, 2024, Bio-Rad issued their initial "Urgent Medical Device Correction" notification via E-Mail. On February 14, 2023, Bio RAD Laboratories issued a revised "Urgent Medical Device Correction" notification via E-Mail. Bio-Rad asked consignees to take the following actions: 1. Confirm past patient results against correct values for Catalog No. 12005560, Batch Nos. 64562656 and 64571846 when provided with corrected calibrator values by Bio-Rad Laboratories. 2. If all the controls values fall within the corrected ranges, no further action is required. If one or more controls are outside the corrected ranges, that particular run should be considered as failed and the results for the patient samples tested within that run should be considered invalid. 3. Please go to Bio-Rad.com for the updated Certificate of Analysis. 4. Please ensure this notice is passed to all those who need to be aware within your organization or to any organization where the impacted devices have been transferred. 5. Please complete and return the attached response form as soon as possible so that we are assured you have received this important communication. 6. This notice has been reported to the appropriate Regulatory Agencies. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in commerce: 33 units
Distribution: US Nationwide distribution in the states of PA, SD, TX, FL, MN.
Product codes and lots: Lot # 64562656 & 64571846/ UDI: 03610521162834

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1358-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code OYX

K181661Class IIQXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. / cleared 2019-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)