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.
Recall
- Recall Number
- Z-0485-2009
- Event Number
- 50075
- Firm
- Dade Behring, Inc.
- FEI Number
- 2517506
- Product Code
- JFY
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- September 29, 2008
- Posted
- December 13, 2008
- Terminated
- March 27, 2009
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101
Description
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.
Reagent may exhibit unflagged inaccurate patient sample results.
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.
Nationwide Distribution.
12,773 cartons