Epocal

This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range.

Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.