Arkray Pulls Test Strips Due To Inaccurate Blood Sugar Readings

April 15, 2016

Arkray is recalling certain test strips due to inaccurate blood sugar readings.

The recall, designated as Class 1 by the FDA, involves 99 boxes of Spotchem II Basic Panel-1 Reagent Test Strip and Spotchem II Glucose Reagent Test Strip. The strips are intended for use with the Spotchem EZ analyzer.

The products were recalled in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee.

They were manufactured from November 2014 to September 2015 and distributed from Feb. 18, 2015 to Oct. 13, 2015.

The test strips are reporting false low blood glucose levels. As a result, when the true levels are above 265 mg/dL, there is a risk that a healthcare provider would not diagnose hyperglycemia in a timely manner. No illnesses or injuries have been reported.

Arkray declined to comment.

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