Dimension Vista High Sensitivity Troponin I — Class II medical device recall Z-2927-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-09-09, distributed nationwide. Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
| Recall number | Z-2927-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2020-07-24 |
| Classified | 2020-09-02 |
| Reported by FDA | 2020-09-09 |
| Terminated | 2023-06-07 |
| Distributed | Nationwide (US) |
| Lot numbers | 20008BB, 20035BC, 20135BB |
| Model numbers | 104471067, K6427 |
Product
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Reason for recall
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
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-2927-2020. 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.