Recall Test Strips due to Inaccurate Blood Sugar Readings

 

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

·         There is a risk that Hyperglycemia, Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome may go undiagnosed

 

Affected products include:

 

·         Lot Numbers: PN5C26 $ EA4M78

·         Manufacturing Dates: November 2014 to September 2015

·         Distribution Dates: February 18, 2015 to October 13, 2015

·         25 foiled packaged test strips per box

 

Recommendations:

·         Return unused product 

·         A Replacement product will be shipped free of charge

·         Report adverse events  to the FDA's MedWatch

·         Complete and submit the report Online:

 

 

Read the MedWatch safety alert @ www.fda.gov/MedWatch/report