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.

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