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.
FDA Recall Z-2419-2010 · Posted 2010-09-16
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2010-02-12
Date Terminated2010-10-13
Product Quantity324
Reason for Recall
The ECREA test results may be falsely elevated or depressed.
Firm 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 contact Siemens Technical Solutions Center at 800-441-9250.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
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.
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