Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2
FDA device recall Z-0709-2007 · posted 2007-05-23 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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 Sal
- Date initiated
- 2006-12-18
- Date posted
- 2007-05-23
- Date terminated
- 2010-12-20
- Location
- Alameda, CA
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