VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the… — Class II medical device recall Z-0878-2023
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-01-11, distributed nationwide. Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an
| Recall number | Z-0878-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2022-11-17 |
| Classified | 2023-01-04 |
| Reported by FDA | 2023-01-11 |
| 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, PT, RU, SE, SG |
| Quantity | 4,158 units |
| UPC / GTIN / UDI-DI | 10758750006267 |
| Lot numbers | 1610, 1621, 1630, 1640, 1645, 1650, 1670 |
| Model numbers | 6802892 |
Product
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Reason for recall
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample 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-0878-2023. 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.