Dimension Enzymatic Creatinine — Class II medical device recall Z-1232-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-02-26, distributed nationwide. There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using t
| Recall number | Z-1232-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-12-18 |
| Classified | 2020-02-14 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,198 units |
| UPC / GTIN / UDI-DI | 00842768030512 |
Product
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Reason for recall
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
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-1232-2020. 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.