Boehringer Mannheim Coaguchek System

• • Terminated Z-0737-2007 FDA Unclassified (pre-2012) ·initiated 28 Feb 2007 ·via K930454, on the same 510(k)

  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 ·via K930454, on the same 510(k)

  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 ·via K930454, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K930454 ↗

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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See all devices from Boehringer Mannheim Corp. →