Z-2177-2011

Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the...

Name: Z-2177-2011 Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-06-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-06-10 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human... on 2010-06-10. The reason FDA records is "Patient results may be falsely depressed or falsely elevated across the assay range". 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-2177-2011
Status: Terminated
Initiated: 2010-06-10
Posted: 2011-05-10
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Patient results may be falsely depressed or falsely elevated across the assay range.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit.
Quantity in commerce: 860
Distribution: Nationwide distribution.
Product codes and lots: Catalog number DF270B - Lot numbers BD1008, CD1050, FA1081 and GA1190.

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)