Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The pro
FDA device recall Z-1196-2009 · posted 2009-05-20 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MDS
- Quantity affected
- 2 units
- Distribution
- US Distribution to states of NY and AZ.
- Date initiated
- 2008-11-01
- Date posted
- 2009-05-20
- Date terminated
- 2009-06-03
- Location
- Alameda, CA
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