Apr

2012

Cl ll OneTouch Verio IQ Blood Glucose Monitoring

Company:Lifescan Inc.
Date of Enforcement Report 4/25/12
Class ll:

PRODUCT
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. Recall # Z-1359-2012

REASON
An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the “Results Log” when the log has 256 or a multiple of 256 items to display.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifescan Inc., Milpitas, CA, by letter dated February 21, 2012.
Manufacturer: Lifescan Europe, A Division Of Cilag Gmbh International, Zug, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide and Canada
___________________________________

About the author

Amy Sellers

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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Cl ll OneTouch Verio IQ Blood Glucose Monitoring

Amy Sellers

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