Terminated

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.

FDA Recall Z-0772-2012 · Posted 2012-01-15

Recalling FirmSiemens Healthcare Diagnostics, Inc.

Recall StatusTerminated

Product CodeCGX

Date Initiated2011-11-22

Date Terminated2014-04-03

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925668CREATININE METH FOR USE ON THE DIMENSION CLIN CHEME.I. Dupont DE Nemours & Co., Inc. · 1992-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.