Roche Homocysteine-In vitro test for the quantitative determination… — Class II medical device recall Z-0679-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-12-25, distributed nationwide. Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
| Recall number | Z-0679-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-10-04 |
| Classified | 2019-12-13 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 82 units |
| Lot numbers | 422313 |
| Model numbers | 06542921190 |
| Expiration dates | 2020-07-31 |
Product
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Reason for recall
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
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-0679-2020. 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.