Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 Recalled by Cepheid Due to Invitro diagnostic test kits with specimens that have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.
Affected Products
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Quantity: 6325 units
Why Was This Recalled?
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Where Was This Sold?
This product was distributed to 29 states: AL, AZ, AR, CA, CO, FL, GA, IL, IA, KS, KY, LA, ME, MD, MI, MN, MO, NE, NH, NJ, NY, NC, OH, PA, RI, TX, VA, WA, WI
About Cepheid
Cepheid has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report