| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00139-1 |
| Product Name/Description |
QXDx BCR-ABL %IS Kit. An in vitro diagnostric medical device (IVD)
Product UDI: 03610521171980
Catalogue Number:12006134
Serial/Lot Numbers: 64549423, 64556965, 64562663, 64572053
Software Version: v1.7.4
ARTG 316116
(Bio-Rad Laboratories Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
During review of data BCR-ABL Value Assignment, it was identified that the Min/Max limits was incorrect for the following two Advanced Reverse Transcriptase (RT) Value Assignments for Catalogue No. 12004571:Â 64541488, 64562640.
Due to the risk of incorrect concentration of BCR-ABL transcripts, there is the potential of incorrect reporting of a lower %IS and Molecular Response values, that may lead to incorrect conclusions that the patient is responding to TKI therapy. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
1. Confirm past patient results against correct values for Catalog No. 12006134, Batch Nos. 64549423, 64555965, 64562663, and 64572053 when provided with corrected calibrator values by Bio-Rad Laboratories.
2. Laboratories should review the results produced with the affected batches and compare the corrected values against the originally reported calibrator and control test results.
- 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. Visit Bio-Rad.com for the updated Certificate of Analysis. |
| Contact Information |
1800 224 354 - Bio-Rad Technical Support |