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Terminated

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

FDA Recall Z-2229-2012 · Posted 2012-08-21

Recalling FirmSunquest Information Systems, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-08-12
Date Terminated2012-09-04
Product Quantity47 sites

Reason for Recall

In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Firm Action

Sunquest sent an Urgent - Product Safety Notice letter dated August 12, 2011 to all affected customers. The letter identified the affected product, summary of the problem, actions to eliminate the problem and actions to be taken by clients. Sunquest will distribute a new maintenance release. Client Support can be reached at 1-877-239-0337 for U.S and Canadian sites and at +44 (0) 101-335-0562 for international sites.

Root Cause

Process design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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