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;
FDA Recall Z-0709-2007 · Posted 2007-05-23
Advertisement
Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2006-12-18
Date Terminated2010-12-20
Product Quantity67,601 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement