Company: Mysis Healthcare Systems, Inc.
Date of Enforcement Report: 9/18/02
Class: II
PRODUCT
Mysis Commercial Laboratory. Recall # Z-1285-2.
REASON
Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR).
CODE
Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a.
RECALLING FIRM/MANUFACTURER
Mysis Healthcare Systems, Inc., Plano, TX, by fax on May 28, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE DISTRIBUTION
Nationwide.
