01

Aug

2007

Class II Radiometer America Blood Gas Analyzers

0

Company:Radiometer America Inc
Date of Enforcement Report:8/1/2007
Class:ll

PRODUCT
a) ABL 700 Series blood gas analyzers equipped with Software Version 3.833, Recall # Z-1094-2007;
b) ABL 800 FLEX series blood gas analyzers containing software version 5.24, Recall # Z-1095-2007;

REASON
Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein removal program instead of the cleaning program, this may damage the reference membrane and result in incorrect pH and electrolyte values being reported.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by Safety Alert Notice on November 13, 2006.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
a) 17 in US;
b) 464 US and Canada

DISTRIBUTION
Nationwide and Canada

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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