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U.S. Department of Health and Human Services

Class 2 Device Recall Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

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  Class 2 Device Recall Contour, Contour TS Blood Glucose Test Strips and Bonus Packs see related information
Date Initiated by Firm August 12, 2011
Date Posted September 19, 2011
Recall Status1 Terminated 3 on July 02, 2012
Recall Number Z-3268-2011
Recall Event ID 59467
510(K)Number K062058  
Product Classification Glucose dehydrogenase, glucose - Product Code LFR
Product Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
Code Information 9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A

9579, 1802, 6181, 7070A, 9725, 9507C, and 9578.   Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
Recalling Firm/
Manufacturer		 Bayer Healthcare, LLC
430 S Beiger Street
Mishawaka IN 46544-3207
For Additional Information Contact Tim Krauskopf
914-333-6057
Manufacturer Reason
for Recall		 All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood
FDA Determined
Cause 2		 Packaging
Action Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.
Quantity in Commerce 3,617,287 vials/ 54,555,460 test strips
Distribution Nationwide Distribution and Puerto Rico
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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