FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, fo
FDA device recall Z-1258-2011 · posted 2011-02-15 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- Product dispositioned for destruction was potentially diverted to end users.
- Action taken
- The firm, Abbott Diabetes Care (ADC), will be posting notification on its Abbott Diabetes Care website. Also, the firm issued an "IMPORTANT: MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2009, to customers ( registered users of Free Style, Free Style Flash, FreeStyle Freedom or Free Style Navigator). For foreign consignees/customers, the firm has issued communication worldwide. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please check the lot number on the test strip carton or vial for the affected product number; if found, discontinue use and call the ADC Customer Care line at: 1-800-310-1500 and the ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent. If you have any questions, please call ADC Customer Care line at 1-800-310-1500.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 1860 units
- Distribution
- The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consigne
- Date initiated
- 2009-03-13
- Date posted
- 2011-02-15
- Date terminated
- 2011-02-15
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 (K051839) | Abbott Diabetes Care, Inc. | 2006-03-09 |