Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Reported: December 24, 2025 Initiated: October 30, 2025 #Z-0959-2026
Product Description
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Reason for Recall
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Details
- Recalling Firm
- Cepheid
- Units Affected
- 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
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10. Recalled by Cepheid. Units affected: 6325 units.
Why was this product recalled? ▼
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0959-2026.
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