FDA Device recall Z-1232-2020
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1232-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-18 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Reason
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.
Identifiers
| code_info | UDI Number: 00842768030512 Lots: All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.