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

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Cepheid
Product: Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Reason / hazard: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Classification: Class II
Status: Ongoing
Distribution / sold at: 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
Recall initiated: 2025-10-30
Code info: UDI: 007332940001834/Lot Numbers: 1001452775 1001457465 1001457622 1001459091 1001462586 1001462625 1001463944 1001465391 1001469480 1001473229 1001474930 1001477474 1001480636 1001483324 1001486594 1001492908 1001493823 1001495811 1001498202 1001501650
Product quantity: 4032 units
Voluntary mandated: Voluntary: Firm initiated
City: Sunnyvale
State: CA
Country: United States
Event id: 98004