FDA-Device2025-12-24Class IIPROCESSING DEFECT
Cepheid Xpert BCR-ABL Ultra test kit recalled for inaccurate results in high white blood cell samples
What this means
Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may give inaccurate results when testing blood samples with very high white blood cell counts (over 30,000 cells). This affects specific lot numbers distributed across the US and internationally. No injuries have been reported.
- Check if your facility has affected lot numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425
- Contact Cepheid or your supplier for instructions on affected test kits
- Review recent test results from these lots, especially for patients with elevated white blood cell counts
The agency's original wording
Hazard
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Intended for
Adults
Illnesses reported
None reported
Sold states
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
Affected count
6325 units
Manufactured in
904 E Caribbean Dr, Sunnyvale, CA, United States
Products
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2026Want us to check the next one for you?
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