VENTANA PD-L1 — Class II medical device recall Z-0907-2023
Ongoing recall by Ventana Medical Systems, Inc., reported 2023-01-18, distributed nationwide. Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of po
| Recall number | Z-0907-2023 |
|---|---|
| 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 | 2022-11-18 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PY, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VN, ZA |
| Quantity | 8,927 kits |
| UPC / GTIN / UDI-DI | 04015630967155, 04015630976591, 07613336106709 |
Product
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Reason for recall
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
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-0907-2023. 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.