Itc Whole Blood Control Normal/Abnormal Level I or II

• 2 recalls, same reason

  • Terminated Z-2107-2010 FDA Unclassified (pre-2012) ·initiated 8 Jul 2010
  • Terminated Z-2108-2010 FDA Unclassified (pre-2012) ·initiated 8 Jul 2010

  Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.

• • Terminated Z-2200-2010 FDA Unclassified (pre-2012) ·initiated 25 Jun 2010

  The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes

• • Terminated Z-1786-2010 FDA Unclassified (pre-2012) ·initiated 15 Apr 2010

  Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.

510(k) Number

K944691 ↗

FDA Product Code

GGN

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemochron(R) Kact

  Class II

  FDA 510(k) K913861 Active Cleared 18 Oct 1991

• Hemochron Jr Generation II, Hemochron Jr Signature

  Class II

  FDA 510(k) K974799 Active Cleared 7 Jul 1998

• Hemochron Citrate Aptt

  Class II

  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Protime Microcoagulation System

  Class II

  FDA 510(k) K951072 Active Cleared 27 Oct 1995

• Tenderfoot

  Class II

  FDA 510(k) K883968 Active Cleared 1 Dec 1988

• Prothrombin Time (Pt) by Hemochron, Modification

  Class II

  FDA 510(k) K911995 Active Cleared 17 Jul 1991

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