Although I don't have a home tester, I know so many of you do and would be interested in this article I received in my email--
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Roche Diagnostics and FDA informed consumers and healthcare
professionals of the recall of CoaguChek PT test strips used to
determine blood clotting time of patients taking anti-coagulant
medication to prevent blood clots. The recall was due to the potential
for a test strip defect that may cause falsely elevated test results,
resulting in an incorrect dose of anti-coagulant medication or
unnecessary corrective measures being taken to reduce the effect of
circulating anti-coagulants. Healthcare professionals who use CoaguChek
PT test strips should institute 'duplicate testing', or use two strips
with different lot numbers, on each patient to reduce the risk of bias.
Home users of CoaguChek PT test strip should immediately discontinue use
of the product and contact their healthcare provider.
Read the complete MedWatch 2006 safety summary, including a link to the
FDA press release at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#CoaguChek
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Roche Diagnostics and FDA informed consumers and healthcare
professionals of the recall of CoaguChek PT test strips used to
determine blood clotting time of patients taking anti-coagulant
medication to prevent blood clots. The recall was due to the potential
for a test strip defect that may cause falsely elevated test results,
resulting in an incorrect dose of anti-coagulant medication or
unnecessary corrective measures being taken to reduce the effect of
circulating anti-coagulants. Healthcare professionals who use CoaguChek
PT test strips should institute 'duplicate testing', or use two strips
with different lot numbers, on each patient to reduce the risk of bias.
Home users of CoaguChek PT test strip should immediately discontinue use
of the product and contact their healthcare provider.
Read the complete MedWatch 2006 safety summary, including a link to the
FDA press release at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#CoaguChek
