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.
FDA Recall Z-0485-2009 · Posted 2008-12-13
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Recalling FirmDade Behring, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2008-09-29
Date Terminated2009-03-27
Product Quantity12,773 cartons
Reason for Recall
Reagent may exhibit unflagged inaccurate patient sample results.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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