FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- Recall number
- Z-1358-2024
- Recalling firm
- Bio-Rad Laboratories
- Product
- Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- Status
- Open, Classified
- Initiated
- 2024-02-15
- Posted
- 2024-03-22
- Terminated
- not on file
- Reason
- Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
- 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
- 33 units
- Distribution
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Lot, serial or model codes
- Lot # 64562656 & 64571846/ UDI: 03610521162834
- 510(k) numbers
- ["K181661"]
- PMA numbers
- not on file
- Product code
- OYX
- Firm FEI
- 3010581187
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28