Recall Z-0959-2026— Cepheid

Name: FDA recall Z-0959-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-30

Class II · Ongoing

Class II FDA medical device recall by Cepheid, initiated 2025-10-30. It names one FDA 510(k) clearance: K190076. Product: Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10. Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results..

Recalling firm: Cepheid
Classification: Class II
Status: Ongoing
Initiated: 2025-10-30
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid·cleared 2019-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.