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CoaguChekĀ® PT Test Strips - Potential for Erroneous Test Results Due to Insufficient Thromboplastin in the Test Strip
Roche Diagnostics has confirmed the potential for random falsely high INR test results with the test strips listed below. To date, the company has confirmed one incident and its internal investigation suggests that a small percentage of strips may be affected.
Affected Product
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Catalog No.
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Lot No.
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CoaguChek PT Test
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Strips 3116247
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All lot numbers
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CoaguChek PST
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Test Strips 3116239
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All lot numbers
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Click here to read the device correction announcement from Roche Diagnostics.
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Monday, December 9, 2024
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