Events

Recall of Device Recall Infinite 200

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tecan US, 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
    69739
  • Event Risk Class
    Class 3
  • Event Number
    Z-0991-2015
  • Event Initiated Date
    2014-11-10
  • Event Date Posted
    2015-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131449
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Reason
    Incorrect lumi firmware version installed (e.027 instead of v2.00).
  • Action
    Tecan sent an Urgent Field Corrective Action letter dated October2014, to all affected consignees by via FedEx on/or about November 10, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use te kinetic luminescence measurement workflow requiring movement of th eplate transport out during kinectice measurements until the firmware has been upgraded to current version 2.0. A Tecan service representative will contact you to arrange a time to install the firmware. Additionally, they may want to review prior measurement results obtained with this workflow. Customers with questions were advised to contacte their local Tecan Helpdesk. For questions regarding this recall call 919-361-5200, ext 19524.

Device

Device Recall Infinite 200
  • Model / Serial
    Material number: 30016056, Lot numbers: 708004532, 810007441, 906000758.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
  • Product Description
    Infinite 200 || The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
  • Manufacturer
    Tecan US, Inc.

Manufacturer

Tecan US, Inc.
  • Manufacturer Address
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • Manufacturer Parent Company (2017)
    Tecan Group AG
  • Source
    USFDA