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U.S. Department of Health and Human Services

Class 2 Device Recall Bayer Contour TS blood glucose test strips

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  Class 2 Device Recall Bayer Contour TS blood glucose test strips see related information
Date Initiated by Firm December 21, 2007
Date Posted March 13, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0932-2008
Recall Event ID 46207
Product Classification Blood Glucose Test System (OTC) - Product Code LFR
Product Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico).
Code Information Test strip lots WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A, WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F, WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B.
Recalling Firm/
Manufacturer		 Bayer Healthcare LLC
430 S Beiger Street
Mishawaka IN 46544-3207
For Additional Information Contact
800-348-8100
Manufacturer Reason
for Recall		 Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.
FDA Determined
Cause 2		 Process design
Action The firm issued a Press Release on 12/21/07. A Test Strip Recall letter was also sent to the firm's consignees and health care providers instructing them that use of the product should cease and that health care providers contact the firm for replacements. Additional information can be found at www.bayerdiabeties.com or by contacting the Bayer at 1-800-348-8100.
Quantity in Commerce 97,000 bottles of test strips
Distribution Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
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.
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