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

Recall date

October 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0960-2026

FDA classification

Class II

Brand / firm

Cepheid

Sold / distributed

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 Sal…

Why it was recalled

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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