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.
- Company
- Dade Behring Inc.
- Recall Initiated
- September 29, 2008
- Posted
- December 13, 2008
- Terminated
- March 27, 2009
- Recall Number
- Z-0485-2009
- Quantity
- 12,773 cartons
- Firm Location
- Newark, DE
Reason for Recall
Reagent may exhibit unflagged inaccurate patient sample results.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
Root Cause
Component design/selection
Action Taken
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.
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