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Recall Observatory FDA recall evidence

Device product

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Z-2270-2012

December 05, 2011

Class II

Product summary

Firm
Sunquest Information Systems, Inc.
Event
Event 62708
Status
Terminated
Classification
Class II
Quantity
127 sites
Official record key
device-enforcement:Z-2270-2012

Official wording

Reason: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

Code information: Versions 6.4 and later

Distribution pattern: Worldwide Distribution -- USA (nationwide) and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.