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Class 2 Device Recall Sunquest Laboratory System. |
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Date Initiated by Firm |
August 01, 2008 |
Date Posted |
November 12, 2008 |
Recall Status1 |
Terminated 3 on November 28, 2011 |
Recall Number |
Z-0214-2009 |
Recall Event ID |
49136 |
Product Classification |
Calculator/Data Processing Module. - Product Code JQP
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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. |
Code Information |
Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. |
Recalling Firm/ Manufacturer |
Sunquest Information Systems, Inc. 250 S Williams Blvd Tucson AZ 85711-4472
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For Additional Information Contact |
520-570-2252
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Manufacturer Reason for Recall |
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
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FDA Determined Cause 2 |
Software design |
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. |
Quantity in Commerce |
139 |
Distribution |
Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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