Epocal Recalls
2 recalls on record · July 25, 2012 to August 21, 2013 · Medical Devices
Recalls by year
12
13
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2013Medical DevicesFDA
Epocal recalls epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potas
Hazard: 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.
July 25, 2012Medical DevicesFDA
Epocal Inc recalls epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blo
Hazard: 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.