Recall Z-0960-2026— Cepheid
Class II · Ongoing
Class II FDA medical device recall by Cepheid, initiated 2025-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10. Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results..
- Recalling firm
- Cepheid
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-30
- Firm location
- Sunnyvale, CA, United States
Product description
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Reason for recall
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.