Arkray announced a recall of the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip due to possible inaccurate blood sugar readings. The products are intended for use with the SPOTCHEM EZ analyzer.
The test strips were found to report falsely low blood glucose when true levels are >265mg/dL. This may result in healthcare providers not diagnosing hyperglycemia, including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome and fail to treat elevated blood glucose levels.
A total of 99 boxes containing 25 foiled packaged test strips per box were recalled in Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio, and Tennessee. The affected products contain Lot # PN5C26 and EA4M78 and were distributed between February 18, 2015 and October 13, 2015.
To date, there have been no reports of illness or injury from the use of SPOTCHEM II Test Strips but serious injury or death are possible. The Company stated that replacement products will be shipped accordingly.
For more information call (877) 538-8872 or visit FDA.gov.