Recall Z-0485-2009 ยท JFY Enzymatic Method, Creatinine
Dade Behring, Inc.
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
| Date | Dec 13, 2008 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | Reagent may exhibit unflagged inaccurate patient sample results. |
| Root cause | Component design/selection |
| Action | The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250. |
| Quantity | 12,773 cartons |
| 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 |