Events

Recall of BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

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
    Recall
  • Event ID
    31146
  • Event Risk Class
    Class 2
  • Event Number
    Z-0574-05
  • Event Initiated Date
    2005-02-15
  • Event Date Posted
    2005-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37361
  • 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.

Device

BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
  • 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
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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