Recall Z-1232-2020 ยท JFY Enzymatic Method, Creatinine
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
| Date | Jan 24, 2020 (initiated Dec 18, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019. |
| Quantity | 2,198 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 Dade Behring, Inc., Jan 3, 2008 |