Creatinine Meth for Use on the Dimension Clin Chem

• • Terminated Z-2741-2015 FDA Class II ·initiated 15 Jul 2015 ·on shared 510(k) K925668

  Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.

• • Terminated Z-0772-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2011

  Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well that has been punctured.

• • Terminated Z-1729-2011 FDA Unclassified (pre-2012) ·initiated 27 Dec 2010

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K925668 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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