FDA Recall Terminated

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 · Initiated August 1, 2008

Recall

Recall Number
Z-0214-2009
Event Number
49136
Firm
Sunquest Information Systems, Inc.
FEI Number
1000306472
Product Code
JQP
Status
Terminated
Root Cause
Software design
Initiated
August 1, 2008
Posted
November 12, 2008
Terminated
November 28, 2011
Address
250 S Williams Blvd, Tucson, AZ, 85711-4472

Description

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.

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 U

Action

A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.

Distribution

Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.

Quantity

139