Events

Recall of Device Recall Infinite M1000

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
    71352
  • Event Risk Class
    Class 2
  • Event Number
    Z-1969-2015
  • Event Initiated Date
    2015-05-29
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137390
  • 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
    A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
  • Action
    Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.

Device

Device Recall Infinite M1000
  • Model / Serial
    Material Number 30034301 and 30061442.  Serial numbers 904004848 807001164 1003005106 808056058 1006007069 1108006370 906001927 811005550 1002002705 1007007321 1110004989 1009005297 910008892 1005008056 1103008195 1009003991 912003102 1007005488 912003960 1008001833 808052054 1005002244 1103001072 909005818 1005008057 1010005921 1004003572 1103008191 1001006206 809004189 907004270 1006007071 1010001688 1010001689 1110004987 1112000054 1107006152 1103008189 902000004 810003913 908006454 1002002702 912003958 1009002602 1007003513 1001007642 1110006961 911008985 908001687 1011003332 909007802 901005834 901005835 1009007093 906000659 812003360 1110004988 1009002603 1001006205 1003005108 1005008055 1112000053 1001001581 1005008053 1003000532 909000550 911000226 910004186 1009003980 1110006962 907000033 907000720 908004917 1001007641 910008890 808052053 808054758 901005836 911006512 1002002703 1003005107 1106008462 912000502 1010005918 909000551 807003935 807003936 907004267 1007007320
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • Product Description
    Infinite M1000 in vitro diagnostic. || Product Usage: || The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/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