Dimension CTNI-In vitro diagnostic test intended to quantitively… — Class II medical device recall Z-1341-2022
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2022-07-13, distributed nationwide. Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th perc
| Recall number | Z-1341-2022 |
|---|---|
| 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 | 2022-05-18 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Terminated | 2025-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, DE, ES, FR, IN, MX, PL, PT, SK |
| UPC / GTIN / UDI-DI | 00842768013836 |
| Lot numbers | BA3088, GA2323 |
| Model numbers | 10444905/RF421C |
| Expiration dates | 2022-11-19, 2023-03-29 |
Product
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Reason for recall
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
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-1341-2022. 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.