Z-1729-2011

Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the...

Name: Z-1729-2011 Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-12-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-12-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human... on 2010-12-27. The reason FDA records is "Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine...". 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-1729-2011
Status: Terminated
Initiated: 2010-12-27
Posted: 2015-06-26
Terminated: 2013-12-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
Reason for recall: Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, SIEMENS, sent an "Urgent Field Safety Notice" dated December 2010 to all customers. The letter described the product ( Dimension(R) CREA Flex(R) Reagent Cartridges DF33A lots BB1286, CA1260 and FB1251), problem and actions to be taken. The customers were instructed to please discontinue use and discard any remaining inventory of the product; complete and return the fax form to the Customer Service Support for replacement of the product; if they must continue use of the product until they receive a replacement, open a new well set every 8 hours to minimize any impact to CREA test results, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the Technical Solution Center at 302-631-8467. If you have any questions, contact the Technical Solution Center at 800-441-9250.
Quantity in commerce: 20,177
Distribution: Worldwide distribution: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.
Product codes and lots: Catalog Number DF33A - Lots BB1286, CA1260 and FB1251

Product code CGX

K925668Class IICreatinine Meth for Use on the Dimension Clin ChemE.I. Dupont DE Nemours & Co., Inc. / cleared 1992-12-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)