11
Feb
2015

Cl II Radiometer ABL90 FLEX analyzer

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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