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U.S. Department of Health and Human Services

Class 1 Device Recall Ascensia Contour Diabetes Care System

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  Class 1 Device Recall Ascensia Contour Diabetes Care System see related information
Date Initiated by Firm June 06, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on November 30, 2007
Recall Number Z-1001-2007
Recall Event ID 38118
510(K)Number K062058  
Product Classification Glucose Monitoring System - Product Code LFR
Product Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
Code Information NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.
Recalling Firm/
Manufacturer		 Bayer Healthcare LLC
430 S Beiger Street
Mishawaka IN 46544-3207
For Additional Information Contact Roger Sonnenburg
574-256-3441
Manufacturer Reason
for Recall		 Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.
FDA Determined
Cause 2		 Other
Action The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.
Quantity in Commerce 16-Canadian Units only are affected
Distribution 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 = LFR and Original Applicant = BAYER HEALTHCARE
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