Recall of BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corp..

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    The parameters loaded in the analyzer for the hepatitis c virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
  • Action
    Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.


  • Model / Serial
    All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Canada.
  • Product Description
    BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
  • Manufacturer


  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source