Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

FDA device recall Z-0073-2013 · posted 2012-10-17 · Terminated

Recall details

Recalling firm

Sunquest Information Systems, Inc.

Reason for recall

Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

Action taken

Urgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Return receipt acknowledging PSN-11-06 is required . Client Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

127 sites

Distribution

Nationwide distribution

Date initiated

2011-11-15

Date posted

2012-10-17

Date terminated

2012-10-19

Location

Tucson, AZ