Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
FDA Recall #Z-2270-2012 — Class II — December 5, 2011
Product Description
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Reason for Recall
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.
Recalling Firm
Sunquest Information Systems, Inc. — Tucson, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
127 sites
Distribution
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Code Information
Versions 6.4 and later
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated