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Recall: 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
· There is a risk that Hyperglycemia, Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome may go undiagnosed
Affected products include:
· Lot Numbers: PN5C26 $ EA4M78
· Manufacturing Dates: November 2014 to September 2015
· Distribution Dates: February 18, 2015 to October 13, 2015
· 25 foiled packaged test strips per box
Recommendations:
· Return unused product
· A Replacement product will be shipped free of charge
· Report adverse events to the FDA's MedWatch
· Complete and submit the report Online:
Read the MedWatch safety alert @ www.fda.gov/MedWatch/report