Recall Z-1813-2008 ยท LFR Glucose Dehydrogenase, Glucose
Abbott Diabetes Care, Inc.
Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
| Date | Sep 11, 2008 (initiated Apr 24, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2954900 strips |
| Distribution | Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992684 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc., Jan 14, 2000 |