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Roche Recalls Lots of Coaguchek Xs Pt Test Strips with FDA's Class I Warning

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Roche Recalls Lots of Coaguchek Xs Pt Test Strips with FDA's Class I Warning

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  • The recall is in response to the inaccurate INR (International Normalized Ratio) results reported byCoaguChek XS PT Test Strips distributed by Terrific Care/Medex Supply including catalogue number that were not included in Roche’s 2018- recall of strips and were not labeled or authorized for sales in the US
  • The FDA Class I recall is for the devices which have serious or harmful effect on the human body leading to death
  • CoaguChek XS PT Test Strips are used in combination with CoaguChek XS plus- CoaguChek XS Pro- CoaguChek XS PST and CoaguChek Vantus test meter devices for monitoring levels of warfarin to examine time taken for blood to clot

   Ref: FDA | Image: Roche 


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