| Class 2 Device Recall BioRad, QXDx BCRABL IS Kit |  |
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/ Manufacturer |
Bio-Rad Laboratories 5731 W Las Positas Blvd Pleasanton CA 94588-4084
|
For Additional Information Contact | Bio Rad Technical Support 1800-424-6723 |
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
|
|
|
|