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Epocal recalls epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potas
Recalled August 21, 2013 · FDA recall Z-1971-2013 · Epocal
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. · FDA Class II
Units
828,750 Test Card
Sold at
Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.
Description
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.
Product
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Manufacturer(s)
Epocal
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →