FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
- Recall number
- Z-2229-2012
- Recalling firm
- Sunquest Information Systems, Inc.
- Product
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
- Status
- Terminated
- Initiated
- 2011-08-12
- Posted
- 2012-08-21
- Terminated
- 2012-09-04
- Reason
- In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
- Root cause
- Process design
- Action
- Sunquest sent an Urgent - Product Safety Notice letter dated August 12, 2011 to all affected customers. The letter identified the affected product, summary of the problem, actions to eliminate the problem and actions to be taken by clients. Sunquest will distribute a new maintenance release. Client Support can be reached at 1-877-239-0337 for U.S and Canadian sites and at +44 (0) 101-335-0562 for international sites.
- Quantity
- 47 sites
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Version 6.4.2
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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