FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-0931-2008
- Recalling firm
- Bayer Healthcare LLC
- Product
- 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).
- Status
- Terminated
- Initiated
- 2007-12-21
- Posted
- 2008-03-13
- Terminated
- 2009-07-07
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LFR
- Firm FEI
- 1826988
- Firm city
- Mishawaka
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28