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.

REASON

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

CODE

All lot numbers for ACS 180 SE Analyzers.

MANUFACTURER

Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY

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

DISTRIBUTION

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

QUANTITY

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.

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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