Class 1 Recall for SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip. Arkray USA, a maker of products for diabetes management, has recalled 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. The test strips may give falsely low blood glucose levels.
The Food and Drug Administration (FDA) has categorized this as a Class I recall, the most serious recall category. Class 1 recall is reserved for devices that may cause serious injuries or death.
The recall covers SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip, lot numbers PN5C26 and EA4M78. The test strips are intended for use with the SPOTCHEM EZ analyzer.
The strips were manufactured from November 2014 to September 2015 and distributed from February 18, 2015 to October 13, 2015. The recalled test strips were distributed in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee.
Test Strip May Report Falsely Low Blood Glucose Level
The recalled 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 report low blood glucose when the level is actually above 265 mg/dL, there is a risk that the health care provider would fail to 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, WebMD explains. When blood glucose is high for too long in a person with type 1 diabetes, the individual may experience a dangerous build-up of acids in the blood called ketoacidosis.
The FDA says that there have not been any reports of illness or injury from the use of the SPOTCHEM II Test Strips, but an inaccurate blood glucose reading from the strips could result in serious injury or death.
Arkray began sending Urgent Medical Device Recall letters to customers on December 18, 2015. The letter identified the affected SPOTCHEM II test strips, gave the reason for recall, and provided instructions for returning unused test strips to the company. Arkray will send test strips to the customer free of charge. Customers may contact Arkray at 1-877-538-8872.
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