Recall Z-1196-2009 ยท MDS Sensor, Glucose, Invasive
Abbott Diabetes Care, Inc.
Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
| Date | May 20, 2009 (initiated Nov 1, 2008) |
| Status | Terminated |
| Reason | The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. |
| Root cause | Packaging process control |
| Action | The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions. |
| Quantity | 2 units |
| Distribution | US Distribution to states of NY and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.