Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System 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(R) 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-2154-2011
- Event Number
- 58379
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- JFY
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 10, 2010
- Posted
- May 9, 2011
- Terminated
- December 19, 2013
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101
Description
Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System 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(R) 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.
Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to: Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method. To notify anyone to whom they may have distributed the product. Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467. For questions regarding this recall call (302) 631-6299.
Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
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