Recall Z-1729-2011 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 | Dec 27, 2010 |
| Status | Terminated |
| Reason | 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 | 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 res |
| Quantity | 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, Portuga |
| 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 |