Recall Z-2177-2011 ยท JFY Enzymatic Method, Creatinine
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.
| Date | May 10, 2011 (initiated Jun 10, 2010) |
| Status | Terminated |
| Reason | Patient results may be falsely depressed or falsely elevated across the assay range. |
| Root cause | Device Design |
| Action | Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit. |
| Quantity | 860 |
| Distribution | Nationwide distribution. |
| 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 |