Arkray USA, which makes products for diabetes management, has announced the recall of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip used to test blood sugar (glucose) levels in patients with diabetes because these test strips may give falsely low blood glucose levels.
The Food and Drug Administration (FDA) has identified this action as a Class I recall, the most serious recall category. Use of these devices may cause serious injuries or death.
The recall includes SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip, lot numbers PN5C26 and EA4M78. The strips were manufactured from November 2014 to September 2015 and distributed from February 18, 2015 to October 13, 2015. The defective test strips were distributed in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee. The test strips are intended for use with the SPOTCHEM EZ analyzer.
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels. Because the test strips are reporting 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 the patient’s elevated blood glucose levels.
Frequent or ongoing high blood sugar can cause damage to nerves, blood vessels, and organs. For people with type 1 diabetes, when blood glucose is high for too long, they may experience a dangerous build-up of acids in the blood called ketoacidosis.
Though to date there have been no reports of illness or injury from the use of the SPOTCHEM II Test Strips, the problem with the strips can lead to serious injury or death, according to the FDA.
Arkray sent an Urgent Medical Device Recall letter to customers beginning on December 18, 2015. The letter identifies the affected products, gave the reason for recall, and provided instructions for returning unused test strips to the firm. Replacement test strips will be sent to the customer free of charge. Customers may contact Arkray at 1-877-538-8872.