Company: Sunquest Information Systems, Inc.
Date of Enforcement Report: 3/7/01
Date of Recall: 1/15/01
Class: II
PRODUCT:
Flexilab Laboratory Information System (not for use in blood banks).
Recall #Z-0369-1.
REASON:
Software anomaly allows misprint of patient information.
CODE:
Flexilab version 5.23 with RBR module.
MANUFACTURER:
Sunquest Information Systems, Inc., Tucson, AZ.
RECALLED BY:
Manufacturer, by fax on January 15, 2001. Firm-initiated recall ongoing.
DISTRIBUTION:
WI, WA, MI, VA, NM, OH, AZ, and Denmark.
QUANTITY:
15 laboratories.