Events

Recall of Device Recall Tecan Genesis Instruments

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
    25850
  • Event Risk Class
    Class 2
  • Event Number
    Z-0869-03
  • Event Initiated Date
    2003-02-27
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26603
  • 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
    Firmware defect. under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner posid2.
  • Action
    Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.

Device

Device Recall Tecan Genesis Instruments
  • Model / Serial
    Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
  • Product Description
    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
  • 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