The United States Food and Drug Administration (FDA) has issued an alert concerning the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip [Lot Numbers: PN5C26 and EA4M78; Manufacturing Dates: November 2014 to September 2015; Distribution Dates: 18 February 2015 to 13 October 2015], manufactured by Arkray Factory Inc.
According to the FDA, the manufacturer 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 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. The issue may cause serious injury or death.
The manufacturer sent an Urgent Medical Device Recall letter to customers in the United States beginning on 18 December 2015. The letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm.
TFor details, please refer to the FDA websites:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=72867&w=01202016%E2%8C%A9=eng
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483792.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm483760.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 January 2016