Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Contour, Contour TS Blood Glucose Test Strips and Bonus Packssee related information
Date Initiated by FirmAugust 12, 2011
Date PostedSeptember 19, 2011
Recall Status1 Terminated 3 on July 02, 2012
Recall NumberZ-3268-2011
Recall Event ID 59467
510(K)NumberK062058 
Product Classification Glucose dehydrogenase, glucose - Product Code LFR
ProductContour, 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 ContactTim 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
ActionBayer 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 Commerce3,617,287 vials/ 54,555,460 test strips
DistributionNationwide Distribution and Puerto Rico
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LFR
-
-