Ventana anti-CD10 — Class II medical device recall Z-2644-2024
Ongoing recall by Ventana Medical Systems, Inc., reported 2024-08-28, distributed nationwide. Their is a potential for high background and off-target staining when using the monoclonal primary antibody wh
| Recall number | Z-2644-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems, Inc., Oro Valley, AZ, United States |
| Recall initiated | 2024-06-27 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PY, RO, RS, SA, SE, SG, SK, SV, TH, TW, UY, VN, ZA |
| Quantity | 22,839 kits |
| UPC / GTIN / UDI-DI | 04015630972579 |
| Model numbers | 790-4506 |
Product
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Reason for recall
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive 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-2644-2024. 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.