Recall Z-1233-2020 ยท JFY Enzymatic Method, Creatinine
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
| 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 | 11,725 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 Siemens Healthcare Diagnostics, Inc., May 22, 2009 |