Events

Recall of Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunquest Information Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62344
  • Event Risk Class
    Class 3
  • Event Number
    Z-2216-2012
  • Event Initiated Date
    2011-04-28
  • Event Date Posted
    2012-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110298
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    In online entry (oex) there are two scenarios where a test result from one container may file to a test on another container. in order for this to occur: 1) site parameter sit 1,2,1,26 (3,217) [restrict resulting of tests to owner container (/n)]=y. 2) the tests are ordered on the same accession number and 3) the test codes are defined to have the same upload code as either replicate or.
  • Action
    Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.

Device

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Manufacturer

Sunquest Information Systems, Inc.
  • Manufacturer Address
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA