06

Jun

2007

Inc, Class II Abbott Diabetes Care

0

Company: Abbott Diabetes Care, Inc
Date of Enforcement Report:5/30/2007
Class:ll

PRODUCT
Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); 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, Recall # Z-0709-2007

REASON
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.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc, Alameda, CA, by letter on December 21, 2006.
Manufacturer: Lahlouh, Burlingame, CA. Recall initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
67,601 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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