Device recall: Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.…
Class II FDA enforcement event 62768. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sunquest Information Systems, Inc. started this device recall on 15 Mar 2012. The firm address in the FDA record is in Tucson, AZ. FDA put the recall in Class II. FDA event 62768 has 1 product record. The first FDA enforcement report date is 19 Sep 2012. The record gives the status Terminated, with the termination date 2 Oct 2012.
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 . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
Recalling firm
Sunquest Information Systems, Inc., Tucson, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2332-2012 | 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… | 126 sites | Class II | Terminated | 19 Sep 2012 |
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.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Dec 2011 | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry | Device | Class II | 1 |
| 15 Nov 2011 | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | Device | Class III | 1 |
| 3 Nov 2011 | Sunquest Laboratory, version 7.0 not available | Device | Class II | 1 |
| 12 Aug 2011 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use | Device | Class III | 1 |
| 28 Apr 2011 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select | Device | Class III | 1 |
| 5 Oct 2010 | Sunquest Laboratory LabAccess Results Workstation (LARS) | Device | Class II | 1 |
| 19 Nov 2009 | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. | Device | Class II | 1 |
| 13 Apr 2009 | Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. | Device | Class III | 1 |
Official channels
- FDA enforcement report Z-2332-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 62768. https://recallregister.com/fda/ii/62768/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
- What quantity of product is in FDA event 62768?
- The FDA record gives this quantity:
126 sites
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.