Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502
FDA device recall Z-1306-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
- Action taken
- On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- approx. 2,365,000 meters (both recall numbers)
- Distribution
- Worldwide
- Date initiated
- 2006-05-22
- Date posted
- 2006-08-03
- Date terminated
- 2006-12-21
- Location
- Alameda, CA
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