Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers

• 5 recalls, same reason

  • Terminated Z-0913-2018 FDA Class II ·initiated 22 Sep 2017 ·on shared 510(k) K062077
  • Terminated Z-0914-2018 FDA Class II ·initiated 22 Sep 2017 ·on shared 510(k) K062077
  • Terminated Z-0915-2018 FDA Class II ·initiated 22 Sep 2017 ·on shared 510(k) K062077
  • Terminated Z-0911-2018 FDA Class II ·initiated 22 Sep 2017 ·on shared 510(k) K062077
  • Terminated Z-0912-2018 FDA Class II ·initiated 22 Sep 2017 ·on shared 510(k) K062077

  This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

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

510(k) Number

K062077 ↗

FDA Product Code

DKZ

Models / Variants

Vitros Chemistry Products Amph Reagent

Calibrator Kit 26

Fs Calibrator 1

Dat Performance Verifiers

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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