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U.S. Department of Health and Human Services

Class 1 Device Recall Abbott Diabetes Care, MediSense Optium

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 Class 1 Recall
Abbott Diabetes Care, MediSense Optium
see related information
Date Posted February 09, 2011
Recall Status1 Terminated on October 25, 2011
Recall Number Z-0996-2011
Recall Event ID 57524
Premarket Notification
510(K) Number
K051213 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;
Code Information 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.
Recalling Firm/
Manufacturer
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, California 94502-7000
For Additional Information Contact J. Scott House
510-749-5400
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 in Commerce 359 total lots, 1,000,000 strips per lot.
Distribution Products were released for distribution in US and Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT LABORATORIES INC
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