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Sunquest Information Systems, Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Sunquest Information Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Sunquest Information Systems, Inc.

Date Product Reason Class
Mar 15, 2012 Sunquest Laboratory Sunquest Laboratory is intended for use by professiona... Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139,... Class II
Dec 5, 2011 Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry The recall was initiated because Sunquest has confirmed that the Sunquest Lab... Class II
Nov 15, 2011 Sunquest Laboratory : intended for use by professionals working in a clini... Online calculations may not be performed as expected or may yield results tha... Class III
Nov 3, 2011 Sunquest Laboratory, version 7.0 not available Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an ... Class II
Aug 12, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage... In GUI inquiry, searching by ID (CID) may return the wrong patient demographi... Class III
Apr 28, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select In Online Entry (OEx) there are two scenarios where a Test result from one co... Class III
Oct 5, 2010 Sunquest Laboratory LabAccess Results Workstation (LARS) The recall was initiated because Sunquest has confirmed that the Sunquest Lab... Class II
Nov 19, 2009 Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface,... The recall was initiated because Sunquest Information System has confirmed re... Class II
Apr 13, 2009 Sunquest Encompass The reporting site is using the Encompass software in a... Sunquest is recalling the Sunquest Encompass versions 2.4 and later because t... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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