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.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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