Xpert BCR-ABL Ultra
CEPHEID · Model GXBCRABL-US-10 · UDI-DI 07332940007102
OYX
Prescription
1
510(k) clearances
6
Adverse events
3
Recalls
7
Facilities
Description
Xpert BCR-ABL Ultra test; 10 test kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-30 | Cepheid | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| 2025-10-30 | Cepheid | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| 2024-02-15 | Bio-Rad Laboratories | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.