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Terminated

Sunquest Laboratory LabAccess Results Workstation (LARS)

FDA Recall Z-2272-2012 · Posted 2012-08-24

Recalling FirmSunquest Information Systems, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2010-10-05
Date Terminated2012-08-24
Product Quantity151 sites

Reason for Recall

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.

Firm Action

An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.

Official Source

View FDA Recall →

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

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