Recall Z-2216-2012— Sunquest Information Systems, Inc.
Class III · Terminated
Class III FDA medical device recall by Sunquest Information Systems, Inc., initiated 2011-04-28, terminated 2012-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select. 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 (<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.
- Recalling firm
- Sunquest Information Systems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2011-04-28
- Terminated
- 2012-09-04
- Firm location
- Tucson, AZ, United States
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
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