FDA Device recall Z-0960-2026
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-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-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-0960-2026 |
| 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-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: 007332940001834/Lot Numbers: 1001452775 1001457465 1001457622 1001459091 1001462586 1001462625 1001463944 10014653…UDI: 007332940001834/Lot Numbers: 1001452775 1001457465 1001457622 1001459091 1001462586 1001462625 1001463944 1001465391 1001469480 1001473229 1001474930 1001477474 1001480636 1001483324 1001486594 1001492908 1001493823 1001495811 1001498202 1001501650 |
|---|
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-0960-2026%22
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