VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27 — Class II medical device recall Z-0476-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-11-28, distributed nationwide. VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
| Recall number | Z-0476-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-10-08 |
| Classified | 2018-11-16 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2022-10-13 |
| 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 |
| Quantity | 5,850 units |
| UPC / GTIN / UDI-DI | 10758750006793 |
| Lot numbers | 1517-26-6396 |
| Expiration dates | 2018-11-06, 2019-02-02, 2019-05-07 |
Product
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Reason for recall
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased 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-0476-2019. 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.