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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad, QXDx BCRABL IS Kit

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  Class 2 Device Recall BioRad, QXDx BCRABL IS Kit see related information
Date Initiated by Firm February 15, 2024
Date Posted March 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1358-2024
Recall Event ID 94020
510(K)Number K181661  
Product Classification BCR/ABL1 monitoring test - Product Code OYX
Product Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Code Information Lot # 64562656 & 64571846/ UDI: 03610521162834
Recalling Firm/
Bio-Rad Laboratories
5731 W Las Positas Blvd
Pleasanton CA 94588-4084
For Additional Information Contact Bio Rad Technical Support
Manufacturer Reason
for Recall
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OYX and Original Applicant = Bio-Rad Laboratories, Inc.