Z-0709-2007

Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and...

Name: Z-0709-2007 Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and...
Creator: Abbott Diabetes Care, Inc.
Published: 2006-12-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-18 / Terminated / root cause: software

FDA source

Abbott Diabetes Care, Inc. began a recall of 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 on 2006-12-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0709-2007
Status: Terminated
Initiated: 2006-12-18
Posted: 2007-05-23
Terminated: 2010-12-20
Recalling firm: Abbott Medical
Product: 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;
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: software
FDA 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 in commerce: 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, 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.
Product codes and lots: 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

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)