Company:Radiometer America Inc
Date of Enforcement Report: 2/11/2015
Class lI:
PRODUCT
ABL90 FLEX analyzer, Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Recall Number Z-1046-2015
REASON
The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
RECALLING FIRM/MANUFACTURER
Radiometer America Inc., Westlake, OH on 12/82014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
5002 units
DISTRIBUTION
Nationwide and Internationally
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