Vitros Chemistry Products Dhdl Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace

• • Terminated Z-0807-2018 FDA Class III ·initiated 10 Jul 2017 ·on shared 510(k) K042006

  VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

• • Terminated Z-0311-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

• • Terminated Z-1316-2012 FDA Not yet classified ·initiated 2 Feb 2012

  Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.

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

510(k) Number

K042006 ↗

FDA Product Code

LBS

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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