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

Recall date

October 30, 2025

Source

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

Recall number

Z-0959-2026

FDA classification

Class II

Brand / firm

Cepheid

Sold / distributed

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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-US-10