Z-0772-2012

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

Name: Z-0772-2012 Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-11-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-11-22 / Terminated

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 2011-11-22. The reason FDA records is "Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well that has been...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0772-2012
Status: Terminated
Initiated: 2011-11-22
Posted: 2012-01-15
Terminated: 2014-04-03
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: Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well that has been punctured.
FDA root cause: Under Investigation by firm
Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated November 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter recommends that customers discontinue and discard any remaining inventory of the affected product. The firm also recommends customers to test QC at least every 8 hours with lots manufactured after lot FA2237. Additionally, a Field Correction Effectiveness Check form was attached to the letter for customers to complete and return via fax to 302-631-8467. Contact the Siemens Customer Service Center at 888-588-3916 for questions regarding this notice.
Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Benin, Bosnia Herzegovina, Botswana, Brazil, Canada, Canary Islands, Ceuta/Mililla, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, France, French Guinea, Germany, Great Britian, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Mexico, Montenegro, Morocco, Nepal, Nether Antilles, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, Yemen and Zimbabwe.
Product codes and lots: Catalog number DF33A and lot numbers GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.

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)