Bio-Rad Laboratories 2024-04-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1358-2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Recall
Issued April 3, 2024 · Bio-Rad Laboratories
In April 2024, Bio-Rad Laboratories recalled the Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
What you should do
- 1 Stop using Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Bio-Rad Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Bio-Rad Laboratories
- Category
- Health
- Recall date
- April 3, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Recall number
- FDA-Z-1358-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Bio-Rad Laboratories has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.