Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- December 22, 2010
- Posted
- February 9, 2011
- Terminated
- October 25, 2011
- Recall Number
- Z-0996-2011
- Quantity
- 359 total lots, 1,000,000 strips per lot.
- Firm Location
- Alameda, CA
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: 45001A159, 45001A195, 45001A228, 45001A233, 45001A236, 45001A243, 45001A247, 45001A249, 45001A250, 45001A255, 45001A279, 45001A285, 45001A295, 45001A298, 45001A306, 45001A317, 45001A318, 45001A327, 45001A346, 45001A398, 45001A449, 45001A469, 45001A578, 45001A693, 45001A697, 45001A747, 45001A790, 45001A795, 45001A839, 45001A917; MediSense Optium Blood Glucose Electrodes: 45001A133, 45001A137, 45001A226, 45001A252, 45001A257, 45001A277, 45001A285, 45001A817, 45001A835, 45001A921, 45001C001.
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.