Events

Recall of Device Recall 300 microliter CORE tips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton Co.

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
    50529
  • Event Risk Class
    Class 2
  • Event Number
    Z-1203-2009
  • Event Initiated Date
    2008-12-01
  • Event Date Posted
    2009-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75704
  • 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
    Device, microtiter diluting/dispensing - Product Code JTC
  • Reason
    Some tips may be occluded and are unable to aspirate or dispense liquid.
  • Action
    An "Urgent: Product Recall Letter" dated December 1, 2008 was issued to consignees via certified mail and e-mail. The letter described the problem and potential effects of use. Consignees were instructed to complete the enclosed "Hamilton Company Product Recall Questionnaire" and return it via e-mail or fax (775-856-7259) to the Hamilton Company. After receipt of the completed questionnaire, the firm's Customer Service Department will contact consignees to provide Returned Material Authorization information for returning affected product. Direct questions to the Hamilton Company at 775-858-3000, ext. 236.

Device

Device Recall 300 microliter CORE tips
  • Model / Serial
    Lot Number: 2873900.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MA, CA, MN, CT, and NC.
  • Product Description
    300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV. || The products are a disposable product that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices.
  • Manufacturer
    Hamilton Co

Manufacturer

Hamilton Co
  • Manufacturer Address
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA