Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 — Class II medical device recall Z-0959-2026
Ongoing recall by Cepheid, reported 2025-12-24, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause
| Recall number | Z-0959-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2025-10-30 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BD, BE, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DZ, EC, ES, FI, FR, GB, GH, GR, GT, HK, HN, ID, IL, IN, IQ, IT, JM, JO, KE, KW, LB, LK, LT, LU, LV, MA, MX, MY, NI, NL, NO, NZ, OM, PE, PH, PL, PT, QA, SA, SE, SG, SV, TH, TN, TW, UY, VE, ZA |
| Quantity | 6,325 units |
| UPC / GTIN / UDI-DI | 07332940007102 |
| Lot numbers | 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425 |
| Model numbers | GXBCRABL-US-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0959-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.