Dimension Vista Chemistry 1 Calibrator, Model KC110

• • Terminated Z-0652-2017 FDA Class II ·initiated 15 Sep 2016

  Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082.

• • Terminated Z-2720-2014 FDA Class II ·initiated 18 Aug 2014

  Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.

• • Terminated Z-0864-2010 FDA Unclassified (pre-2012) ·initiated 31 Aug 2009

  Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.

510(k) Number

K061838 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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