FDA Device

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;

Hazard

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.

What You Should Do

Remedy

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.

Products

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;
Brand
Abbott Diabetes Care, Inc.
UPC
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

Units Affected

67,601 units