Events

Recall of Sunquest Laboratory SMART and 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
    62452
  • Event Risk Class
    Class 3
  • Event Number
    Z-2229-2012
  • Event Initiated Date
    2011-08-12
  • Event Date Posted
    2012-08-21
  • 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=110692
  • 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 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.
  • 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.

Device

Sunquest Laboratory SMART and 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