Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Enforcement
- Recall Number
- Z-0960-2026
- Event ID
- 98004
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cepheid
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 24, 2025
- Initiation Date
- October 30, 2025
- Classification Date
- December 18, 2025
- Address
- 904 E Caribbean Dr, Sunnyvale, CA, 94089-1189, United States
Description
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
UDI: 007332940001834/Lot Numbers: 1001452775 1001457465 1001457622 1001459091 1001462586 1001462625 1001463944 1001465391 1001469480 1001473229 1001474930 1001477474 1001480636 1001483324 1001486594 1001492908 1001493823 1001495811 1001498202 1001501650
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4032 units