Events

Recall of Device Recall LIAISON Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin 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
    50704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1042-2009
  • Event Initiated Date
    2008-12-05
  • Event Date Posted
    2009-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76461
  • 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
    Colorimeter, Photometer, Spectrophotometer for clinical use - Product Code JJQ
  • Reason
    Diasorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the liaison (r) analyzer.
  • Action
    DiaSorin Inc authorized Field Service Engineer has visited the sites and performed the necessary field correction. Upon completion of their work, the field service engineer generated a Field Service Report and a copy was left with the customer.

Device

Device Recall LIAISON Analyzer
  • Model / Serial
    Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of Canada.
  • Product Description
    Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. || Colorimeter, Photometer, Spectrophotometer for clinical use.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA