Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
FDA device recall Z-2229-2012 · posted 2012-08-21 · Terminated
Recall details
- Recalling firm
- Sunquest Information Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 47 sites
- Distribution
- US Nationwide Distribution
- Date initiated
- 2011-08-12
- Date posted
- 2012-08-21
- Date terminated
- 2012-09-04
- Location
- Tucson, AZ
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