| Class 1 Device Recall Abbott Diabetes Care Precision Xceed Pro | |
Date Initiated by Firm | December 22, 2010 |
Date Posted | February 09, 2011 |
Recall Status1 |
Terminated 3 on October 25, 2011 |
Recall Number | Z-0994-2011 |
Recall Event ID |
57524 |
510(K)Number | K070984 |
Product Classification |
Blood Glucose Test Strips - Product Code NBW
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Product | Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips |
Code Information |
Lot codes: 44535H, 44545H, 44565H, 445A5H, 44645H, 44665H, 446E5H, 44725H, 44755H, 44925H, 44945H, 44945H, 44975H, 44995H, 449A5H, 44A15H, 44A35H, 44A75H, 44A85H, 44C65H, 44C75H, 44CE5H, 44CH5H, 44CP5H, 44CR5H, 45025H, 45035H, 450A5H, 450C5H |
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 |
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 of 1,000,000 strips each. |
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
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