Z-2216-2012 Class III Terminated
FDA device recall Z-2216-2012 was initiated by Sunquest Information Systems, Inc. on April 28, 2011 and is designated Class III. Reason for recall: 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) [Rest… The recall status is terminated (terminated September 4, 2012). Affected quantity: 103 sites.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2012
- Initiation Date
- April 28, 2011
- Termination Date
- September 4, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103 sites
Product Description
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Reason for Recall
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 (<Y>/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
Distribution Pattern
Nationwide Distribution
Code Information
Version 6.3.0 and Later