Bio-Rad recalls QXDx BCR- 12005660 kits with incorrect calibrations that may cause inaccurate molecular response reporting. Affected lots: 64562656, 64571846. No remedy stated in recall notice.
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Bio-Rad is recalling specific QXDx BCR-ABL %IS Kits due to potential incorrect reporting of molecular response values. This could lead to inaccurate test results, which might affect patient treatment decisions.
The kits have incorrect calibrations and controls that may cause the reported molecular response values to be too low. This could lead to misinterpretation of test results, potentially affecting treatment decisions for patients with certain blood conditions.
Healthcare professionals using the QXDx BCR-ABL %IS Kit for blood tests are most at risk. Patients relying on these tests for treatment decisions could be impacted by inaccurate results.
Check the lot numbers: 64562656 or 64571846. The unique device identifier (UDI) is 03610521162834. These kits were sold by Bio-Rad Laboratories.
Look for lot numbers 64562656 or 64571846 on the kit packaging.
The recall is due to incorrect calibrations and controls that may cause inaccurate reporting of molecular response values.
The recall notice does not specify a remedy, so no action is required beyond checking the lot number.
Check the lot numbers: 64562656 or 64571846, and the unique device identifier (UDI) 03610521162834.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1358-2024 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1358-2024 from Bio-Rad. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
