Sunquest Information Systems, Inc.: FDA recalls

FDA enforcement reports name Sunquest Information Systems, Inc. as the recalling firm in 9 events. The events have 9 product records. The recalls started from 2009 to 2012. All the events are device recalls.

See the 9 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

9 events, newest first.

FDA enforcement events of Sunquest Information Systems, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
15 Mar 2012	Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow…	Device	Class II	1	Terminated
5 Dec 2011	Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry	Device	Class II	1	Terminated
15 Nov 2011	Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.	Device	Class III	1	Terminated
3 Nov 2011	Sunquest Laboratory, version 7.0 not available	Device	Class II	1	Terminated
12 Aug 2011	Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use	Device	Class III	1	Terminated
28 Apr 2011	Sunquest Laboratory SMART & Sunquest Laboratory SMART Select	Device	Class III	1	Terminated
5 Oct 2010	Sunquest Laboratory LabAccess Results Workstation (LARS)	Device	Class II	1	Terminated
19 Nov 2009	Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.	Device	Class II	1	Terminated
13 Apr 2009	Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.	Device	Class III	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Sunquest Information Systems, Inc.: events for each product type
Type		Events
Device		9

Sunquest Information Systems, Inc.: events in each class
Class		Events
Class II		5
Class III		4

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Sunquest Information Systems, Inc., by the year that the recall started. The largest year is 2011, with 5 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Sunquest Information Systems, Inc.: FDA recalls. https://recallregister.com/firm/sunquest-information-systems-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: AZ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Sunquest Information Systems, Inc. have?: Class II: 5 events. Class III: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Sunquest Information Systems, Inc.?: FDA event 62768, which the firm started on 15 Mar 2012. The first product in the record is: Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow…
How many FDA recalls of Sunquest Information Systems, Inc. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.