Bio-Rad recall
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Why was Bio-Rad recalled?
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 64562656 & 64571846/ UDI: 03610521162834
- Product
- Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- Recalling firm
- Bio-Rad Laboratories
- Quantity
- 33 units
- Distribution
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)