FDA Medical Device Recalls (openFDA)
Bayer Healthcare LLC: Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
- Recall number
- Z-1001-2007
- Recalling firm
- Bayer Healthcare LLC
- Product
- Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
- Status
- Terminated
- Initiated
- 2007-06-06
- Posted
- 2007-07-03
- Terminated
- 2007-11-30
- Reason
- Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.
- Root cause
- Other
- Action
- The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.
- Quantity
- 16-Canadian Units only are affected
- Distribution
- Canada.
- Lot, serial or model codes
- NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.
- 510(k) numbers
- ["K062058"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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