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Terminated

Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.

FDA Recall Z-1729-2011 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCGX
Date Initiated2010-12-27
Date Terminated2013-12-21
Product Quantity20,177

Reason for Recall

Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.

Firm Action

The firm, SIEMENS, sent an "Urgent Field Safety Notice" dated December 2010 to all customers. The letter described the product ( Dimension(R) CREA Flex(R) Reagent Cartridges DF33A lots BB1286, CA1260 and FB1251), problem and actions to be taken. The customers were instructed to please discontinue use and discard any remaining inventory of the product; complete and return the fax form to the Customer Service Support for replacement of the product; if they must continue use of the product until they receive a replacement, open a new well set every 8 hours to minimize any impact to CREA test results, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the Technical Solution Center at 302-631-8467. If you have any questions, contact the Technical Solution Center at 800-441-9250.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide distribution: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925668CREATININE METH FOR USE ON THE DIMENSION CLIN CHEME.I. Dupont DE Nemours & Co., Inc. · 1992-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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