Medical Device Safety and Recalls: Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings

Arkray is recalling the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome in a timely manner and fail to treat elevated blood glucose levels.

There have been no reports of illness or injury from the use of the SPOTCHEM II Test Strips, but this issue may cause serious injury or death.

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