VITROS Chemistry Products VALP Reagent Pack — Class II medical device recall Z-0848-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-02-27, distributed nationwide. Negative bias results when using VITROS VALP Reagent, GEN 25.
| Recall number | Z-0848-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-12-11 |
| Classified | 2019-02-19 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750006748 |
| Lot numbers | 25-5503, 25-5727, 25-5974, 25-6067, 25-6393 |
| Model numbers | 6801710 |
Product
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Reason for recall
Negative bias results when using VITROS VALP Reagent, GEN 25.
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-0848-2019. 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.