Blood sugar test strips are being recalled due to inaccurate readings, according to a warning from the Food and Drug Administration (FDA).
SPOTCHEM II Basic PANEL-1 Reagent Test Strips and SPOTCHEM II Glucose Reagent Test Strips (Arkray Factory Inc.) may report falsely low blood glucose levels that could lead to a missed diagnosis of hyperglycemia potentially resulting in injury or death, the warning said. No illnesses have been reported.
Affected products include 99 boxes in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee with lot numbers PN5C26 and EA4M78 distributed between Feb. 18, 2015, and Oct. 13, 2015. Arkray has notified customers and plans to ship replacement products free of charge.
Customers and health care providers can report adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.
