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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 Optiumsee related information
Date Initiated by FirmDecember 22, 2010
Date PostedFebruary 09, 2011
Recall Status1 Terminated 3 on October 25, 2011
Recall NumberZ-0996-2011
Recall Event ID 57524
510(K)NumberK051213 
Product Classification Blood Glucose Test Strips and electrodes - Product Code NBW
ProductAbbott 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 CA 94502-7000
For Additional Information ContactJ. 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		Process control
ActionOn 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 Commerce359 total lots, 1,000,000 strips per lot.
DistributionProducts were released for distribution in US and Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NBW
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