Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affect
FDA device recall Z-1001-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare LLC
- Reason for recall
- Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 16-Canadian Units only are affected
- Distribution
- Canada.
- Date initiated
- 2007-06-06
- Date posted
- 2007-07-03
- Date terminated
- 2007-11-30
- Location
- Mishawaka, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 (K062058) | Bayer Healthcare | 2006-09-11 |