Xpert BCR-ABL Ultra (Cepheid) – Test Result Inaccuracy (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Brand
Cepheid
Lot Codes / Batch Numbers
UDI: 07332940007102/ Lot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425
Products Sold
UDI: 07332940007102/ Lot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425
Cepheid is recalling Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 due to Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, FL, GA, IL, IA, KS, KY, LA, ME, MD, MI, MN, MO, NE, NH, NJ, NY, NC, OH, PA, RI, TX, VA, WA, WI
Page updated: Jan 10, 2026