Stratus (R) Cs Stat Fluorometric Analyzer, Stratus (R) Cs Ckmb Test Pak

• • Terminated Z-2525-2016 FDA Class II ·initiated 22 Jun 2016

  Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.

• • Terminated Z-0343-2011 FDA Unclassified (pre-2012) ·initiated 7 Dec 2009

  Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.

• • Terminated Z-0875-06 FDA Unclassified (pre-2012) ·initiated 3 Apr 2006

  Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

510(k) Number

K984067 ↗

FDA Product Code

JHX

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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