Z-0959-2026Class II

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

Name: Z-0959-2026 Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Creator: Cepheid
Published: 2025-10-30
License: https://open.fda.gov/license/

Cepheid / initiated 2025-10-30 / Open, Classified / root cause: manufacturing process

FDA source

Cepheid began a recall of Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 on 2025-10-30. FDA classified it as Class II and gives the reason as "Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0959-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-30
Posted: 2025-12-18
Recalling firm: Cepheid
Product: Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Product code: OYX Bcr/Abl1 Monitoring Test
Reason for recall: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 6325 units
Distribution: US: 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 Salvador Eswatini Finland France Frenc.Polynesia Gambia Georgia Germany Ghana Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iraq Israel Italy Jamaica Jordan Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Luxembourg Malawi Malaysia Mauritania Mauritius Mexico Morocco Mozambique Myanmar Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pap. New Guinea Peru Philippines Poland Portugal Qatar Rep.of Congo Reunion Rwanda Saudi Arabia Senegal Seychelles Singapore South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tajikistan Tanzania Thailand Togo Tunisia Uganda United Kingdom Uruguay Utd.Arab Emir. Venezuela Zambia Zimbabwe
Product codes and lots: UDI: 07332940007102/ Lot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0960-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code OYX

K190076Class IIXpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid / cleared 2019-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)