ACS 180 SE Analyzer Class II 15 units

CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall#Z-369-9.


Software error causes 16 different assays to not calculate SI units correctly.


All lot numbers for ACS 180 SE Analyzers.


Chiron Diagnostics Corporation, Oberlin, Ohio.


Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete.


Texas, Virginia, Massachusetts, Kentucky, New York, New Jersey, Maryland, Astralia,Belgium, France,
UK, Spain.


15 units were distributed.

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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