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Recall Observatory FDA recall evidence

Device product

Sunquest Laboratory, version 7.0 not available

Z-0250-2013

November 03, 2011

Class II

Product summary

Firm
Sunquest Information Systems, Inc.
Event
Event 63369
Status
Terminated
Classification
Class II
Quantity
14 sites
Official record key
device-enforcement:Z-0250-2013

Official wording

Reason: Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Code information: not available

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.