Company: Sunquest Laboratory System
Date of Enforcement Report 11/9/2008
Class:ll
PRODUCT
Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
Recall # Z-0214-2009
REASON
While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache) was not communicated or displayed in the Graphic User Interface (GUI) application so the activity continued. While this error was registered in the error log in the System Utilities (Function UTL), suboption 2, System Error/Message Inquiry, it was not displayed to the user. The user is still able to use the application on the GUI, although the application will eventually crash. Rarely, this will not occur and the user will not be able to receive errors that could include quality assurance errors for blood-typing, diagnostic test results, and related information.
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by email on August 1, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
139 units
DISTRIBUTION
Nationwide, Canada, Denmark, Saudi Arabia and United Arab Emirates
