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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Blood Glucose Test Strips

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  Class 2 Device Recall Precision Blood Glucose Test Strips see related information
Date Initiated by Firm November 08, 2002
Date Posted December 31, 2002
Recall Status1 Terminated 3 on February 13, 2017
Recall Number Z-0403-03
Recall Event ID 25087
510(K)Number k983504  
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product Precision PCx Test Strips
Part Number: 98757-12
Code Information Lot Number: 146135
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc.
4-A Crosby Drive
Bedford MA 01730
For Additional Information Contact Tina Mazurkiewicz
781-2761111 Ext. 7720
Manufacturer Reason
for Recall		 Use of glucose blood strips may provide false high results
FDA Determined
Cause 2		 Other
Action Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Quantity in Commerce 210 packages
Distribution NC, WI
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 = CGA and Original Applicant = MEDISENSE, INC.
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