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FDA: Arkray recalls Spotchem II Test Strips

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Arkray issued a recall of the Spotchem II Basic Panel-1 Reagent Test Strip and Spotchem II Glucose Reagent Test Strip due to a possibility of reporting false low blood glucose levels.

The strips have been found to incorrectly report low levels when levels are about 265 mg/dL leading to a risk for health care providers not diagnosing hyperglycemia, including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner.

The issue may cause serious injury or death. No reports of illness or injury have been reported.

An Urgent Medical Device Recall letter was sent on Dec. 18, 2015. For a list of the lot numbers recalled see the press release for more information.