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Recall Observatory FDA recall evidence

Device product

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

Z-2229-2012

August 12, 2011

Class III

Product summary

Firm
Sunquest Information Systems, Inc.
Event
Event 62452
Status
Terminated
Classification
Class III
Quantity
47 sites
Official record key
device-enforcement:Z-2229-2012

Official wording

Reason: In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Code information: Version 6.4.2

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.