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

Recalled December 24, 2025 · FDA recall Z-0960-2026 · Cepheid

Hazard

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

Units

4032 units

Sold at

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Description

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

Product

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

Manufacturer(s)

Cepheid

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →