Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Recalled by Sunquest Information Systems, Inc. Due to In Online Entry (OEx) there are two scenarios...

Date: April 28, 2011
Company: Sunquest Information Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sunquest Information Systems, Inc. directly.

Affected Products

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Quantity: 103 sites

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sunquest Information Systems, Inc.

Sunquest Information Systems, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report