ACS Chemiluminescence System Class II 29 units

CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9.


A software error for Troponin I analysis caused erroneous results.


All ACS 180 Plus Analyzers with test definition AL software version.


Chiron Diagnostics Corporation, Oberlin, Ohio.


Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete.




38 ACS 180 Plus Analyzers 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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