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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Link Software

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 Class 2 Recall
Precision Link Software
see related information
Date Posted May 23, 2007
Recall Status1 Open
Recall Number Z-0709-2007
Recall Event ID 37385
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;
Code Information Part Numbers: 99040-01,99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01, 80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02
Recalling Firm/
Manufacturer
Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda, California 94502-7000
Manufacturer Reason
for Recall
If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.
FDA Determined
Cause 2
DESIGN: Software Design
Action Firm initiated its recall on 12/21/2006. The firm provided customer letters with additional information (eg. flyer or insert) to customers that they had addresses for via fedex. In addition, the product notification was posted on the firm's internet website. Further, a flyer is to be included as a supplement to the user manual.
Quantity in Commerce 67,601 units
Distribution Worldwide Distribution: USA as well as abroad to Argentina, Aruba, Australia, Austria, Bahamas, Belgium, Canada, Colombia, Croatia, Curacao, Czech/Slovak Republics, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Latvia, Lithuania/Estonia (Baltics), Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Portugal, Saudi Arabia, Serbia, Bulgaria/Macedonia, Singapore, Slovenia, South Africa, Spain, St. Maarten, Sweden, Switzerland, Turkey, UK and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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