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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 Device Recall Precision Link Softwaresee related information
Date Initiated by FirmDecember 18, 2006
Date PostedMay 23, 2007
Recall Status1 Terminated 3 on December 20, 2010
Recall NumberZ-0709-2007
Recall Event ID 37385
Product Classification Glucose test system - Product Code NBW
ProductAbbott 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 CA 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		Other
ActionFirm 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 Commerce67,601 units
DistributionWorldwide 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 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.
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