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
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