ACS Chemiluminescence System Class II 1015 units

CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9.

REASON

Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements.

CODE

All serial numbers for the ACS 180 and ACS 180 Plus Analyzers.

MANUFACTURER

Chiron Diagnostics Corp., Oberlin, Ohio.

RECALLED BY

Manufacturer, by letter dated June 14, 1996. Firm-initiated recall complete.

DISTRIBUTION

Nationwide and international.

QUANTITY

1,015 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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