[pending] Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Pending LLM rewrite. Source: FDA_DEVICE Z-0960-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
The recalled product
- Product
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
- Manufacturer
- Cepheid
- Category
- Medical Device — Devices
Distribution
Distributed in 29 states:
- 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
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