ONLINE TDM Vancomycin 100 tests — Class II medical device recall Z-2304-2016
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-08-10, distributed nationwide. Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the co
| Recall number | Z-2304-2016 |
|---|---|
| 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 | 2016-05-26 |
| Classified | 2016-08-01 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 53,897 units |
| Reason classes | potency |
Product
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
Reason for recall
Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.
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-2304-2016. 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.