Abbott Alcyon 300 Analyzer 535 units Class II

1/13/00 Class II

PRODUCT

Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic
use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z-
462/463-0.

REASON

Software program errors cause incorrect association between patient and
the patient results.

CODE

All codes.
MANUFACTURER

Abbott Laboratories, Inc., Irving, Texas.

RECALLED BY

Manufacturer, by letter dated January 13, 2000. Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide and Puerto Rico.

QUANTITY

535 analyzers distributed in the United States from 5/1/98 to 12/1/99.

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
Partners located in the US (CA, FL, MA, MN, TX) and Canada.