Date Initiated by Firm |
December 22, 2010 |
Date Posted |
February 09, 2011 |
Recall Status1 |
Terminated 3 on October 25, 2011 |
Recall Number |
Z-0998-2011 |
Recall Event ID |
57524 |
510(K)Number |
K070984
|
Product Classification |
Blood Glucose Test Strips - Product Code NBW
|
Product |
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
|
Code Information |
Lot codes: 45515, 45517, 45701, 45791, 45963, 45964, 46367 |
Recalling Firm/ Manufacturer |
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda CA 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 |
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.
|
510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
|