More INR Test Strips Recalled Due to Inaccurately High Results

The action follows an earlier recall of more than 1.1 million packages of CoaguChek XS PT test strips.

More INR Test Strips Recalled Due to Inaccurately High Results

A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings.

Roche Diagnostics initiated a recall of more than 1.1 million packages of the test strips in September, an action the US Food and Drug Administration categorized as a class I recall, the most serious type, in November.

Now, in a related action announced Thursday on the FDA website, all lots of CoaguChek test strips distributed by Terrific Care/Medex Supply are being recalled.

Roche Diagnostics started receiving reports of abnormal INR readings using the test strips after it recalibrated the strips to a new international standard. A falsely high INR result could lead to a reduction in warfarin dose, interruption of treatment, or administration of vitamin K.

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