Sunquest Laboratory SMART & Sunquest Laboratory SMART recall
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Why was Sunquest Laboratory SMART & Sunquest Laboratory SMART recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 6.3.0 and Later
- Product
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- Recalling firm
- Sunquest Information Systems, Inc.
- Quantity
- 103 sites
- Distribution
- Nationwide Distribution
- Recall date
- August 22, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)