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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 Stripssee related information
Date Initiated by FirmNovember 08, 2002
Date PostedDecember 31, 2002
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-0403-03
Recall Event ID 25087
510(K)NumberK983504 
Product Classification Glucose Oxidase, Glucose - Product Code CGA
ProductPrecision 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 ContactTina Mazurkiewicz
781-2761111 Ext. 7720
Manufacturer Reason
for Recall		Use of glucose blood strips may provide false high results
FDA Determined
Cause 2		Other
ActionAbbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Quantity in Commerce210 packages
DistributionNC, WI
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 = CGA
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