Events

Recall of 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
    52667
  • Event Risk Class
    Class 3
  • Event Number
    Z-1999-2009
  • Event Initiated Date
    2009-04-09
  • Event Date Posted
    2009-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83601
  • 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
    Microliter CO-RE Tips - Product Code JTC
  • Reason
    Product defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.
  • Action
    The firm initiated the recall on April 10, 2009, and issued notification to consignees via certified mail and e-mail. Customers were instructed to return the affected product to the Hamilton Company. A fax-back form was supplied with each notification. Direct questions about the recall to the Hamilton Company by calling 1-775-858-3000, extension 236.

Device

Microliter CORE Tips
  • Model / Serial
    Part Number 235950 (case containing 11,520 tips), Lot Number 2950441 and Part Number 235902 (case containing 5,760 tips), Lot Number 2950461.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of DE, NJ, PA, MA and CA), New Zealand and Japan.
  • Product Description
    300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV. || Product is a disposable product used with 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