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.
Recall
- Recall Number
- Z-2419-2010
- Event Number
- 54682
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- JFY
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 12, 2010
- Posted
- September 16, 2010
- Terminated
- October 13, 2010
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101
Description
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.
The ECREA test results may be falsely elevated or depressed.
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 contact Siemens Technical Solutions Center at 800-441-9250.
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.
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