Events

Recall of Device Recall BioTek Gen5CL Microplate Data Collection and Analysis Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioTek Instruments, 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
    52218
  • Event Risk Class
    Class 2
  • Event Number
    Z-2223-2009
  • Event Initiated Date
    2009-03-12
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82545
  • 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
    Software design allowed false negatives to be read when wells are dark.
  • Action
    BioTek Instruments, Inc. issued a "Product Recall Notification" dated March 13, 2009 information customers of the affected product. Follow-up letters with software installation instructions were sent March 25, 2009. For further information, contact BioTek Instruments, Inc. at 1-888-451-5171 extension 405.

Device

Device Recall BioTek Gen5CL Microplate Data Collection and Analysis Software
  • Model / Serial
    Software versions 1.07 and lower.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.
  • Product Description
    BioTek Gen5CL Microplate Data Collection and Analysis Software. || Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.
  • Manufacturer
    BioTek Instruments, Inc.

Manufacturer

BioTek Instruments, Inc.
  • Manufacturer Address
    BioTek Instruments, Inc., Highland Park/Box 998, Winooski VT 05404
  • Manufacturer Parent Company (2017)
    Lionheart Technologies Inc
  • Source
    USFDA