Kodak Ektachem Clin. Chem. Slides (Amyl)

• 4 recalls, same reason

  • Terminated Z-2364-2020 FDA Class II ·initiated 11 May 2020
  • Terminated Z-2366-2020 FDA Class II ·initiated 11 May 2020
  • Terminated Z-2367-2020 FDA Class II ·initiated 11 May 2020
  • Terminated Z-2365-2020 FDA Class II ·initiated 11 May 2020

  Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.

• • Terminated Z-0298-2014 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.

510(k) Number

K812027 ↗

FDA Product Code

CIW

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →