Recall Z-0772-2012 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jan 15, 2012 (initiated Nov 22, 2011) |
| Status | Terminated |
| Reason | 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. |
| 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- |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925668 | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM E.I. Dupont DE Nemours & Co., Inc., Dec 28, 1992 |