Events

Recall of Disposable Tips (Diti), Conductive, with Filter, 1000l

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
    34159
  • Event Risk Class
    Class 2
  • Event Number
    Z-0326-06
  • Event Initiated Date
    2005-04-11
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43206
  • 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
    Double filtering of 1000 ¿l tips. the defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.
  • Action
    The consignee was notified via fax''d letter on/about 11/08/2005.

Device

Disposable Tips (Diti), Conductive, with Filter, 1000l
  • Model / Serial
    Part Number 10612523, Lot No. U122098L-1325, Lot No. U122098L-3225 & Lot No. U122098L-2325. The sub-lot numbers (i.e. 1325, 3225 and 2325) are printed on each blister and stamped in blue colour on the shipping container in the upper right corner of the box.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL and Europe
  • Product Description
    Disposable Tips 1000 ¿l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestra¿e 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs.
  • Manufacturer
    Tecan U S Inc

Manufacturer

Tecan U S Inc
  • Manufacturer Address
    Tecan U S Inc, 4022 Stirrup Creek Rd., Research Triangle Park NC 27709
  • Source
    USFDA