Recall Z-2419-2010 ยท JFY Enzymatic Method, Creatinine
Siemens Healthcare Diagnostics, Inc.
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes.
| Date | Sep 16, 2010 (initiated Feb 12, 2010) |
| Status | Terminated |
| Reason | The ECREA test results may be falsely elevated or depressed. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Field Safety Notice dated February 2010 to all affected customers. The letter described the product, the problem, and the action to be taken by the customers. The customers were instructed to immediately discontinue the use of and discard the ECREA Flex reagent cartridge lot 09224AA. Customers are to contact their Siemens Customer Service Center at 800-241-0420 to report their additional no-charge replacement needs, and complete and return the enclosed Field Correction Effectiveness Check Form via Fax at 302-631-8467. For any technical questions regarding this Recall |
| Quantity | 324 |
| Distribution | Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 Siemens Healthcare Diagnostics, Inc., May 22, 2009 |