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
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.
조치
Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System || Product Usage: Usage: || epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system