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U.S. Department of Health and Human Services

Class 2 Device Recall epoc BGEM Test Card

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  Class 2 Device Recall epoc BGEM Test Card see related information
Date Initiated by Firm August 28, 2020
Create Date September 15, 2020
Recall Status1 Terminated 3 on September 09, 2021
Recall Number Z-2970-2020
Recall Event ID 86378
510(K)Number K200107  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care
SMN#/Model #: 10736382
Code Information Lot Number: 01-20095-10
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact SAME
781-269-3000
Manufacturer Reason
for Recall		 Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
FDA Determined
Cause 2		 Process control
Action Siemens issued Urgent Medical Device Correction letter on August 28, 2020 via Federal Express stating the reason for recall communication letter informs customers of the issue and, health risk and action take: Please dispose any inventory of test card lot 01-20095-10 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of these products and assess your laboratorys replacement needs. Please use epoc BGEM Test Card from another unaffected lot. Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 463 boxes (50 test cards/box )
Distribution Nationwide Foreign: Canada
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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