Coaguchek System, Coaguchek System for Prothrombin Time Self Testing

• • Terminated Z-0737-2007 FDA Unclassified (pre-2012) ·initiated 28 Feb 2007 ·on shared 510(k) K974569

  The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

• • Terminated Z-0227-2007 FDA Unclassified (pre-2012) ·initiated 18 Oct 2006 ·on shared 510(k) K974569

  Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.

• • Terminated Z-0099-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2005 ·on shared 510(k) K974569

  Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

• • Terminated Z-1293-03 FDA Unclassified (pre-2012) ·initiated 12 Sep 2003 ·on shared 510(k) K974569

  Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.

• • Terminated Z-0720-03 FDA Unclassified (pre-2012) ·initiated 20 Feb 2003

  Discrepancy between INR and the % Quick displayed on the meter.

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

510(k) Number

K974569 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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