Company:International Technidyne Corp.
Date of Enforcement Report 7/6/2011
Class ll:
PRODUCT
a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated. Recall # Z-2218-2011
REASON
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
RECALLING FIRM/MANUFACTURER
International Technidyne Corp. Edison, NJ, by letter dated March 23, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide, Taiwan and Thailand
