Company:Sendx Medical Inc
Date of Enforcement Report 11/14/12
Class ll:

PRODUCT

ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting. Recall Number Z-0195-2013

REASON
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.

RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad , CA on 1/6/2010. Voluntary: Firm Initiated recall has been terminated

VOLUME OF PRODUCT IN COMMERCE
767 units

DISTRIBUTION
Nationwide and Internationally

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