FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: 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 number
- Z-0214-2009
- Recalling firm
- Sunquest Information Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-08-01
- Posted
- 2008-11-12
- Terminated
- 2011-11-28
- 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
- Root cause
- 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
- 139
- Distribution
- Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
- Lot, serial or model codes
- Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000306472
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28