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Recall Observatory FDA recall evidence

Device product

Sunquest Laboratory LabAccess Results Workstation (LARS)

Z-2272-2012

October 05, 2010

Class II

Product summary

Firm
Sunquest Information Systems, Inc.
Event
Event 62714
Status
Terminated
Classification
Class II
Quantity
151 sites
Official record key
device-enforcement:Z-2272-2012

Official wording

Reason: 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.

Code information: Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3

Distribution pattern: Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.