Roche Diagnostics Recalls CoaguChek PT Test Strips

Lee Coleman
Lee Coleman
Contributor
Posted by Lee ColemanOctober 25, 2006 6:42 AM

The FDA and Roche Diagnostic issued a recall of CoaguChek PT test strips due to a potential for a defect that may cause falsely elevated test results. The test strips are used for people on blood thinners. Roche discovered that when insufficient active ingredient (thromboplastin) is applied to the test strip, it can cause a false elevated result. This can cause an incorrect dose of anti-coagulant or other corrective measures to reduce the effect of circulating anti-coagulants. Both could put patients at risk for blood clots. All home users of the CoaguChek PT test strips are asked to immediately discontinue and discard the product and contact their health provider for alternate testing options. Questions or concerns can be directed to Roche Diagnostics Point-of-Care Technical Service at 1-800-820-0995.

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