Recall Z-0931-2008 ยท LFR Glucose Dehydrogenase, Glucose
Bayer Healthcare LLC
Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico).
| Date | Mar 13, 2008 (initiated Dec 21, 2007) |
| Status | Terminated |
| Reason | InaccurateTest Strip 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. |
| Root cause | 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 | 97,000 bottles of test strips |
| Distribution | Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.