Sunquest Information Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2216-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Product Classification:

Class III

Date Initiated: April 28, 2011

Date Posted: August 22, 2012

Recall Number: Z-2216-2012

Event ID: 62344

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

Status: Terminated

Product Quantity: 103 sites

Code Information:

Version 6.3.0 and Later

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated