Recall Z-0709-2007 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
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;
| Date | May 23, 2007 (initiated Dec 18, 2006) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 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 Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Latvia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.