Z-2272-2012Class II

Sunquest Laboratory LabAccess Results Workstation (LARS)

Name: Z-2272-2012 Sunquest Laboratory LabAccess Results Workstation (LARS)
Creator: Sunquest Information Systems, Inc.
Published: 2010-10-05
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2010-10-05 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory LabAccess Results Workstation (LARS) on 2010-10-05. FDA classified it as Class II and gives the reason as "The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2272-2012
Classification: Class II
Status: Terminated
Initiated: 2010-10-05
Posted: 2012-08-24
Terminated: 2012-08-24
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory LabAccess Results Workstation (LARS)
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
Root cause tag: software
FDA root cause: Software design
Action: An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.
Quantity in commerce: 151 sites
Distribution: Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
Product codes and lots: Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2272-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2272-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-24

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)