Z-2419-2010

Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the...

Name: Z-2419-2010 Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-02-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum... on 2010-02-12. The reason FDA records is "The ECREA test results may be falsely elevated or depressed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2419-2010
Status: Terminated
Initiated: 2010-02-12
Posted: 2010-09-16
Terminated: 2010-10-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista 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: The ECREA test results may be falsely elevated or depressed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Field Safety Notice dated February 2010 to all affected customers. The letter described the product, the problem, and the action to be taken by the customers. The customers were instructed to immediately discontinue the use of and discard the ECREA Flex reagent cartridge lot 09224AA. Customers are to contact their Siemens Customer Service Center at 800-241-0420 to report their additional no-charge replacement needs, and complete and return the enclosed Field Correction Effectiveness Check Form via Fax at 302-631-8467. For any technical questions regarding this Recall contact Siemens Technical Solutions Center at 800-441-9250.
Quantity in commerce: 324
Distribution: Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands.
Product codes and lots: Catalog number K1270. Lot number 09224AA

Product code JFY

K090330Class IIDimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models K1270, Kc270Siemens Healthcare Diagnostics, Inc. / cleared 2009-05-22

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)