FDA Device

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Hazard

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 (/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 You Should Do

Remedy

Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.

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Products

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Brand
Sunquest Information Systems, Inc.
UPC
Version 6.3.0 and Later

Units Affected

103 sites

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