Z-0485-2009

Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test...

Name: Z-0485-2009 Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test...
Creator: Dade Behring, Inc.
Published: 2008-09-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-09-29 / Terminated / root cause: design

FDA source

Dade Behring, Inc. began a recall of Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in... on 2008-09-29. The reason FDA records is "Reagent may exhibit unflagged inaccurate patient sample results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0485-2009
Status: Terminated
Initiated: 2008-09-29
Posted: 2008-12-13
Terminated: 2009-03-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Reagent may exhibit unflagged inaccurate patient sample results.
Root cause tag: design
FDA 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 in commerce: 12,773 cartons
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.

Product code JFY

K073055Class IIDimension Enzymatic Creatinine Flex Reagent Cartridge with Model Df270Dade Behring, Inc. / cleared 2008-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)