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Class 1 Device Recall Abbott Diabetes Care Optium EZ |
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Date Initiated by Firm |
December 22, 2010 |
Date Posted |
February 09, 2011 |
Recall Status1 |
Terminated 3 on October 25, 2011 |
Recall Number |
Z-0995-2011 |
Recall Event ID |
57524 |
510(K)Number |
K081975
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Product Classification |
Blood Glucose Test Strips - Product Code NBW
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Product |
Abbott Diabetes Care Optium EZ Blood Glucose Test Strips;
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Code Information |
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 |
Recalling Firm/ Manufacturer |
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda CA 94502-7000
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For Additional Information Contact |
J. Scott House 510-749-5400
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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