January 28, 2016, the FDA initiated a Class I recall of SPOTCHEM II Basic PANEL-1 Reagent Test Strips and SPOTCHEM II Glucose Reagent Test Strips. This Class I recall is the most serious type of recall as they involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
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 due to a lowered reaction rate in the reagent pad for glucose. Because the test strips are reporting falsely 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 elevated blood glucose levels.
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are used to test blood sugar (glucose) levels in blood samples. This product is intended for use with the SPOTCHEM EZ analyzer.
There have been no reports of illness or injury from the use of the SPOTCHEM II Test Strips, but this issue may cause serious injury or death. Affected products include:
- Lot Numbers: PN5C26 and EA4M78
- Manufacturing Dates: November 2014 to September 2015
- Distribution Dates: February 18, 2015 to October 13, 2015
Ninety nine boxes (25 foiled packaged test strips per box) of the product has been distributed in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio, and Tennessee.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, May 2014 Report: Diabetes and Its Complications: Malpractice and Other Liability Issues