Feb

2011

Recall – Cl ll ABL90 FLEX Blood Analyzer

Company: Radiometer America Inc.
Date of Enforcement Report 2/9/2011
Class ll:

PRODUCT
ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall # Z-1011-2011.

REASON
Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample “fails” the next result will inherit the patient data from the previous result.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letters on November 16, 2010.
Manufactaurer:Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
432 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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Recall – Cl ll ABL90 FLEX Blood Analyzer

Amy Sellers

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