FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: Sunquest Laboratory LabAccess Results Workstation (LARS)
- Recall number
- Z-2272-2012
- Recalling firm
- Sunquest Information Systems, Inc.
- Product
- Sunquest Laboratory LabAccess Results Workstation (LARS)
- Status
- Terminated
- Initiated
- 2010-10-05
- Posted
- 2012-08-24
- Terminated
- 2012-08-24
- Reason
- The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
- Root cause
- Software design
- Action
- An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.
- Quantity
- 151 sites
- Distribution
- Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
- Lot, serial or model codes
- Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
- 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