Sunquest Laboratory LabAccess Results Workstation (LARS)
FDA device recall Z-2272-2012 · posted 2012-08-24 · Terminated
Recall details
- Recalling firm
- Sunquest Information Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 151 sites
- Distribution
- Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
- Date initiated
- 2010-10-05
- Date posted
- 2012-08-24
- Date terminated
- 2012-08-24
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.