Dimension LOCI High Sensitivity Troponin I — Class II medical device recall Z-0052-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-10-14, distributed nationwide. Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot.
| Recall number | Z-0052-2021 |
|---|---|
| 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 | 2020-08-19 |
| Classified | 2020-10-02 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2023-08-25 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00842768037726 |
| Lot numbers | EB0255 |
| Model numbers | 10471068, RF627 |
Product
Dimension LOCI 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: RF627, SMN# 10471068
Reason for recall
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
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-0052-2021. 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.