Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
FDA device recall Z-1813-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.
- Action taken
- Recall initiated on April 24, 2008. An Urgent Medical Device Correction was issued to customers. Consignees were notified, along with registered users of the FreeStyle Freedom meters, via recall letters, visits or phone calls. Distributors will be notified, along with the creation of customer lists and tracking of communications to sub-recall. If you have any questions call Tina Mazurkiewicz at 1-800-777-6565.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 2954900 strips
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark.
- Date initiated
- 2008-04-24
- Date posted
- 2008-09-11
- Date terminated
- 2011-03-29
- Location
- Alameda, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (K992684) | Abbott Diabetes Care, Inc. | 2000-01-14 |