Events

Recall of Device Recall Tecan Genesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tecan U S 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
    29238
  • Event Risk Class
    Class 1
  • Event Number
    Z-1022-04
  • Event Initiated Date
    2004-05-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33375
  • 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
    Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
  • Reason
    Tecan software has the potential to match the patient with a different patient's test results.
  • Action
    Consignees were notified by letter on May 3, 2004

Device

Device Recall Tecan Genesis
  • Model / Serial
    PN 10-410 Tecan Genesis 150/8 Back End Configuration,  PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
  • Product Description
    Tecan Clinical Workstations with Robonet software
  • Manufacturer
    Tecan U S Inc

Manufacturer

Tecan U S Inc
  • Manufacturer Address
    Tecan U S Inc, 4022 Stirrup Creek Rd,Ste310, Durham NC 27709
  • Source
    USFDA