Recall Z-1001-2007 ยท LFR Glucose Dehydrogenase, Glucose
Bayer Healthcare LLC
Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
| Date | Jul 3, 2007 (initiated Jun 6, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 Bayer Healthcare, Sep 11, 2006 |