Recall Z-1306-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
| Date | Aug 3, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | approx. 2,365,000 meters (both recall numbers) |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.