ACS Chemiluminescence System Class II 29 units

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

REASON

A software error for Troponin I analysis caused erroneous results.

CODE

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

MANUFACTURER

Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY

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

DISTRIBUTION

Nationwide.

QUANTITY

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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