Class II — Bio-Rad Laboratories
| Recalling firm | Bio-Rad Laboratories (Bio-Rad Services France) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. |
| Product | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit |
| Quantity | 33 units |
| Distribution | US Nationwide distribution in the states of PA, SD, TX, FL, MN. |
| Initiated | 2024-02-15 |
| Classified | 2024-03-22 |
| Recall number | Z-1358-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bio-Rad Laboratories (Z-1358-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94020/
Alerts for Bio-Rad Laboratories (Bio-Rad Services France)
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.