FDA Medical devices recall ·
Xpert¿ BCR-ABL Ultra Model recall
- Recall number
- Z-0959-2026
- Date
- (initiated October 30, 2025)
- Company / brand
- Cepheid
904 E Caribbean Dr, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6325 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Why was it recalled?
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 07332940007102/ Lot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425
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
States: Arkansas Arizona California Florida Georgia Iowa Illinois Kansas Kentucky Maryland Michigan Minnesota Missouri North Carolina Nebraska New Hampshire New Jersey New York Rhode Island Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0959-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.