FDA Device recall Z-0959-2026
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 by Cepheid, citing invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0959-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-30 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cepheid |
| Distribution | 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 |
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.
Identifiers
| code_info | UDI: 07332940007102/ Lot Numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2026%22
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