Events

Recall of Device Recall Sunquest Laboratory Versions 6.4

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
    62708
  • Event Risk Class
    Class 2
  • Event Number
    Z-2270-2012
  • Event Initiated Date
    2011-12-05
  • Event Date Posted
    2012-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111472
  • 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
    The recall was initiated because sunquest has confirmed that the sunquest laboratory versions 6.4 and later while using microbiology result entry (mre), the specimen ribbon containing the accession number (an) and the battery name may be missing or contain the wrong information.
  • Action
    Sunquest sent a recall letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your reply to this email message serves as verification you have received, read, understood and/or followed instructions outlined in the attached Product Safety Notification. Your reply assists Sunquest Information Systems to satisfy our obligation to Regulatory Agencies. Please note in your email reply if your site will not be requesting the software correction. If your site plans to request the software correction, please follow the directions noted on the attached PSN. Further questions please call (520) 570-2347.

Device

Device Recall Sunquest Laboratory Versions 6.4

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