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Problems With Bayer Contour Test Strips
http://www.fda.gov/bbs/topics/ENFORC.../ENF01048.html
FDA Enforcement Report March 19, 2008
PRODUCT
a) Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico), Recall # Z-0931-2008;
b) Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico), Recall # Z-0932-2008
CODE
a) 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;
b) 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, Mishawaka, IN, by press release and letter on December 21, 2007. Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
97,000 bottles of test strips
DISTRIBUTION
Nationwide and Internationally
This appears to only affect the "starter" strips which come with a new Bayer Contour TS meter. So if you've purchased one of these, please take a minute to check the strip codes.
FDA Enforcement Report March 19, 2008
PRODUCT
a) Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico), Recall # Z-0931-2008;
b) Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico), Recall # Z-0932-2008
CODE
a) 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;
b) 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, Mishawaka, IN, by press release and letter on December 21, 2007. Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
97,000 bottles of test strips
DISTRIBUTION
Nationwide and Internationally
This appears to only affect the "starter" strips which come with a new Bayer Contour TS meter. So if you've purchased one of these, please take a minute to check the strip codes.