The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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: February 18, 2015 to October 13, 2015
- Devices Recalled in the U.S.: 99 boxes (25 foiled packaged test strips per box) in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee
The Arkray Factory Inc. 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.
Reason for Recall
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. 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.
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.
Who may be affected
- Patients being evaluated by health care providers using the SPOTCHEM glucose test system who have elevated glucose values greater than 265 mg/dl.
What to Do
The firm sent an Urgent Medical Device Recall letter to customers beginning on December 18, 2015. The letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm. The letter stated that replacement product will be shipped accordingly and provided free of charge.
Customers with questions are instructed to call Arkray at 1-877-538-8872.
Date Recall Initiated
December 18, 2015
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- Class 1 Device Recall SPOTCHEM II Glucose test strips
- Class 1 Device Recall SPOTCHEM II Basic Panel test strips