# FDA recall Z-0959-2026

> **Cepheid** · Class II · device recall initiated 2025-10-30.

## Product

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.

## Distribution

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 Salvador	Eswatini	Finland	France	Frenc.Polynesia	Gambia	Georgia	Germany	Ghana	Greece	Guadeloupe	Guatemala	Honduras	Hong Kong	India	Indonesia	Iraq	Israel	Italy	Jamaica	Jordan	Kazakhstan	Kenya	Kuwait	Latvia	Lebanon	Lithuania	Luxembourg	Malawi	Malaysia	Mauritania	Mauritius	Mexico	Morocco	Mozambique	Myanmar	Netherlands	New Caledonia	New Zealand	Nicaragua	Norway	Oman	Pap. New Guinea	Peru	Philippines	Poland	Portugal	Qatar	Rep.of Congo	Reunion	Rwanda	Saudi Arabia	Senegal	Seychelles	Singapore	South Africa	Spain	Sri Lanka	Sweden	Switzerland	Taiwan	Tajikistan	Tanzania	Thailand	Togo	Tunisia	Uganda	United Kingdom	Uruguay	Utd.Arab Emir.	Venezuela	Zambia	Zimbabwe

## Key facts

- **Recall number:** Z-0959-2026
- **Recalling firm:** Cepheid
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-30
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2026

## Citation

> AI Analytics. FDA recall Z-0959-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0959-2026. Source: US FDA. Licensed CC0.

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