Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and...
FDA Recall #Z-0251-2013 — Class II — November 19, 2009
Product Description
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Reason for Recall
The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
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
9 units
Distribution
Nationwide Distribution.
Code Information
v3.0.0_07222004 and later
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated