Z-0251-2013 Class II Terminated

Recalled by Sunquest Information Systems, Inc. — Tucson, AZ

FDA device recall Z-0251-2013 was initiated by Sunquest Information Systems, Inc. on November 19, 2009 and is designated Class II. 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. The recall status is terminated (terminated November 6, 2012). Affected quantity: 9 units.

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
November 19, 2009
Termination Date
November 6, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

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.

Distribution Pattern

Nationwide Distribution.

Code Information

v3.0.0_07222004 and later