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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 Device Recall Abbott Diabetes Care, MediSense Optium see related information
Date Initiated by Firm December 22, 2010
Date Posting Updated February 09, 2011
Recall Status1 Terminated 3 on October 25, 2011
Recall Number Z-0996-2011
Recall Event ID 57524
510(K)Number K051213  
Product Classification Blood Glucose Test Strips and electrodes - 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/
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda CA 94502-7000
For Additional Information Contact J. Scott House
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT LABORATORIES INC