Recall Z-0959-2026

Reason for recall

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

FDA-determined cause: Process design

Action taken

On 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 WBCCC exceeds 30,000 cells/uL, the specimen should be processed in the accordance with the Retest Procedure for ERROR (Code 2008) or INVALID (Type 2) as detailed in the IFU for the following scenarios: - Cases where INVALID test results are observed and are associated with an elevated WBCC. - Cases of valid results in which an elevated WBCC has been observed. 3. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 4. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them with a copy of this letter. 5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.