Z-2154-2011

Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The...

Name: Z-2154-2011 Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System 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 Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the... on 2010-06-10. The reason FDA records is "Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL 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-2154-2011
Status: Terminated
Initiated: 2010-06-10
Posted: 2011-05-09
Terminated: 2013-12-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System 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(R) 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: Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to: Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method. To notify anyone to whom they may have distributed the product. Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467. For questions regarding this recall call (302) 631-6299.
Quantity in commerce: 1,399
Distribution: Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
Product codes and lots: Catalog number K1270 - lot numbers 09224AA, 09286AA, 09350AC, 10011AF, 10047AA, 10089AC, 10089AD, 10131AC and 10131AD.

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)