Events

Recall of ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

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
    32608
  • Event Risk Class
    Class 3
  • Event Number
    Z-1576-05
  • Event Initiated Date
    2004-03-09
  • Event Date Posted
    2005-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40427
  • 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
    Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus - Product Code MZO
  • Reason
    An error in the acceptance specification for the substrate blank optical density was discovered in the bio-tek elx800 programming specifications for the ortho hcv version 3.0 elisa test system assay.
  • Action
    Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.

Device

ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA ...
  • Model / Serial
    version 12 and older software
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
  • Product Description
    ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
  • 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