ClearanceBrief
Recall Z-0960-2026 ยท OYX Bcr/Abl1 Monitoring Test

Cepheid

Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

DateDec 18, 2025 (initiated Oct 30, 2025)
StatusOpen, Classified
ReasonInvitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Root causeProcess design
ActionOn November 14, 2025, Cepheid issued a "Urgent Medical Device Recall" notification to affected consignees. Cepheid asked consignees to take the following actions: 1. Cepheid recommends that laboratories and clinical facilities utilizing the Xpert BCR-ABL Ultra assay for quantification of BCR::ABL1 and ABL1 mRNA transcript levels in peripheral blood specimens from t(9;22)-positive chronic myeloid leukemia (CML) patients undergoing tyrosine kinase inhibitor (TKI) therapy, assess white blood cell count (WBCC) prior to testing in cases where elevated white blood cell count is suspected. 2. If W
Quantity4032 units
DistributionUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colombia Cyprus Czech Republic Dem. Rep. Congo Djibouti Dominican Rep. Ecuador El Sal
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.