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U.S. Department of Health and Human Services

Class 2 Device Recall epoc Blood Analysis BGEM Test Cards

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  Class 2 Device Recall epoc Blood Analysis BGEM Test Cards see related information
Date Initiated by Firm June 28, 2011
Date Posted July 19, 2012
Recall Status1 Terminated 3 on December 18, 2013
Recall Number Z-2034-2012
Recall Event ID 61147
510(K)Number K090109  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product 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
Code Information Catalog #CT-1004-00-00, lot number 07-11087-00
Recalling Firm/
Manufacturer		 Epocal Inc
2060 Walkley Rd
Ottawa Canada Ontario
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 8,650
Distribution US nationwide Distribution in the state of CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = EPOCAL, INC.
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