Z-1317-2008

LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and...

Name: Z-1317-2008 LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and...
Creator: Lifescan Inc
Published: 2007-12-18
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2007-12-18 / Terminated / root cause: software

FDA source

Lifescan Inc began a recall of LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan... on 2007-12-18. The reason FDA records is "Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily". 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-1317-2008
Status: Terminated
Initiated: 2007-12-18
Posted: 2008-04-08
Terminated: 2008-07-18
Recalling firm: Lifescan, Inc.
Product: LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.
Quantity in commerce: 260 units
Distribution: Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.
Product codes and lots: Part Number: 021-722-01

Product code NBW

K984527Class IIIn Touch Diabetes Management SoftwareLifescan, Inc. / cleared 1999-04-29

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)