Abbott Diabetes Care Optium EZ Blood Glucose Test Strips;
This recall has been terminated (originally issued February 9, 2011).
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- December 22, 2010
- Posted
- February 9, 2011
- Terminated
- October 25, 2011
- Recall Number
- Z-0995-2011
- Quantity
- 359 total lots, 1,000,000 strips per lot.
- Firm Location
- Alameda, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Products were released for distribution in US and Puerto Rico.
Lot / Code Info
Lot codes: 45358, 45369, 45377, 45504, 45677, 45678, 45681, 45789, 45841, 45848, 45849, 45999, 46000, 46008, 46061, 46067, 46102, 46104, 46117, 46159, 46179, 46201, 46202, 46211, 46230, 46247, 46311, 46312, 46341, 46368, 46369, 46371, 46395, 46399, 46401, 46436
Root Cause
Process control
Action Taken
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.