Neoplastine Ci Plus

• • Terminated Z-2993-2018 FDA Class II ·initiated 24 Jul 2018

  QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

• 3 recalls, same reason

  • Terminated Z-1066-2018 FDA Class II ·initiated 25 Oct 2017
  • Terminated Z-1069-2018 FDA Class II ·initiated 25 Oct 2017
  • Terminated Z-1067-2018 FDA Class II ·initiated 25 Oct 2017

  Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

• • Terminated Z-0979-2007 FDA Unclassified (pre-2012) ·initiated 30 Mar 2007

  Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

510(k) Number

K922040 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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