QXDx BCR-ABL Kit (Bio-Rad) – Calibration Inaccuracy (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.