U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Glucose oxidase, glucose - Product Code CGA
원인
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.
조치
On March 13th 2013, Epocal placed all CT-1004-00-00 test card on shipment hold. Affected product in Epocal control has been segregated and quarantined. Beginning on March 26 2013, Epocal Inc. plans to begin distribution of the Recall Notification Letter to the 4 direct consignees (customers/distributors) via certified mail. Included with the Recall Notification Letter is a faxback verification form. Notification will include all distribution channels to the end-user level. Direct consignees are instructed to discontinue use and discard all stock on hand, complete the provided faxback verification form to document disposal and contact their consignees to advise them of the notification and disposal of affected product.
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.
제품 설명
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.