Recall Z-0995-2011 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
Abbott Diabetes Care Optium EZ Blood Glucose Test Strips;
| Date | Feb 9, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. |
| Root cause | Process control |
| Action | On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned. |
| Quantity | 359 total lots, 1,000,000 strips per lot. |
| Distribution | Products were released for distribution in US and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081975 | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) Abbott Diabetes Care, Inc., Nov 26, 2008 |