Cepheid 2025-12-24 Health serious FDA
Health · FDA · Recall #FDA-Z-0960-2026
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 Recall
Issued December 24, 2025 · Cepheid
In December 2025, Cepheid recalled the Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
What you should do
- 1 Stop using Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cepheid to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cepheid
- Category
- Health
- Recall date
- December 24, 2025
- Units affected
- Not reported
- 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 B
- Recall number
- FDA-Z-0960-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Cepheid has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.