Events

Recall of Device Recall Sunquest Laboratory

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
    62768
  • Event Risk Class
    Class 2
  • Event Number
    Z-2332-2012
  • Event Initiated Date
    2012-03-15
  • Event Date Posted
    2012-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111675
  • 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
    Sunquest is recalling sunquest laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the windows-based merge application is used and the "event merge across patients" option is used, a receiving system (for example a his or copath system) may interpret the event merge as a full patient merge. this occurs because a trigger from the laboratory system for the event.
  • Action
    The firm, Sunquest, sent an "Urgent- Product Safety Notice: PSN-12-02" dated March 15, 2012 to all their customers who purchased the Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1. The notice described the product, the problems and the actions to be taken. Customers were instructed to request the software correction by creating a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Customers with questions were instructed to contact Client support at (877) 239-6337 for US and Canadian Sites and at +44 (0) 161 335 0562 for international sites.

Device

Device Recall Sunquest Laboratory
  • Model / Serial
    Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
  • Product Description
    Sunquest Laboratory || Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.
  • Manufacturer
    Sunquest Information Systems, Inc.

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