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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.