25
Mar
1998

ACS Chemiluminescence System Class II 6 units

0

ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostictests. Recall #Z-363-9.

REASON

Software errors for V1.0 which could lead to erroneous test results.

CODE

All lot numbers for the ACS Centaur.

MANUFACTURER

Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY

Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete.

DISTRIBUTION

Germany and Italy.

QUANTITY

6 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.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.