VITROS Chemistry Products-HCY Reagent packaged in a kit carton — Class II medical device recall Z-1556-2013
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-06-26, distributed nationwide. The firm is recalling the specific lot due to lower than expected results.
| Recall number | Z-1556-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-04-01 |
| Classified | 2013-06-18 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2017-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Lot numbers | 1529-17-2636 |
| Model numbers | 6802002 |
| Expiration dates | 2013-06-12 |
Product
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Reason for recall
The firm is recalling the specific lot due to lower than expected 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-1556-2013. 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.