Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka
FDA device recall Z-0931-2008 · posted 2008-03-13 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 97,000 bottles of test strips
- Distribution
- Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
- Date initiated
- 2007-12-21
- Date posted
- 2008-03-13
- Date terminated
- 2009-07-07
- Location
- Mishawaka, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.