Z-2229-2012 Class III Terminated
FDA device recall Z-2229-2012 was initiated by Sunquest Information Systems, Inc. on August 12, 2011 and is designated Class III. 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. The recall status is terminated (terminated September 4, 2012). Affected quantity: 47 sites.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2012
- Initiation Date
- August 12, 2011
- Termination Date
- September 4, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 sites
Product Description
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Version 6.4.2