Company: Radiometer America Inc.
Date of Enforcement Report 10/3/2018
Class lI:

PRODUCT

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Product #: ABL90 FLEX analyzers with software versions 3.3MR1 or below.

Recall Number: Z-0010-2019

REASON
The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again

RECALLING FIRM/MANUFACTURER
Radiometer America Inc. Brea, CA on 5/25/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
12,102

DISTRIBUTION
US Distribution and Internationally to Canada

___________________________________