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.
FDA Recall Z-2154-2011 · Posted 2011-05-09
Advertisement
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2010-06-10
Date Terminated2013-12-19
Product Quantity1,399
Reason for Recall
Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement