FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- Recall number
- Z-2216-2012
- Recalling firm
- Sunquest Information Systems, Inc.
- Product
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- Status
- Terminated
- Initiated
- 2011-04-28
- Posted
- 2012-08-16
- Terminated
- 2012-09-04
- Reason
- In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
- Root cause
- Software design
- Action
- Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.
- Quantity
- 103 sites
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Version 6.3.0 and Later
- 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