16
Apr
2008

LifeScan OneTouch Data Management Software Cl IIl

0

Company: LifeScan OneTouch Data Management Software Version 1.0
Date of Enforcement Report 4/16/2008
Class:lll

PRODUCT
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), Recall # Z-1317-2008

REASON
Meter Temporarily Freezes– A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

RECALLING FIRM/MANUFACTURER
LifeScan, INC., Milpitas, CA, by letter on December 18, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
260 customers to date have the recalled software drivers.

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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