Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0959-2026
• FDA 510(k) clearance · K190076The device's official FDA premarket clearance record
• FDA device classification · OYXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.6060The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CepheidSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.