Events

Recall of Device Recall ML STAR Sample Carriers

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
    38335
  • Event Risk Class
    Class 2
  • Event Number
    Z-0718-2008
  • Event Initiated Date
    2007-06-25
  • Event Date Posted
    2008-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53453
  • 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
    Microtiter diluting/dispensing device - Product Code JTC
  • Reason
    Incorrectly labeled-- product has the wrong barcode labeling. the barcode error will not influence the results of testing. the instrument will discover the error and post an error notice.
  • Action
    The firm sent an Urgent: Product Recall letter to consignees on June 25, 2007. The firm also issued an alert via their User news distribution. They instructed consignees to examine their stock and return any affected carriers. A fax back form was supplied with the notification. The firm will be providing replacements.

Device

Device Recall ML STAR Sample Carriers
  • Model / Serial
    Serial Numbers: S0213281 to S0214480.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.
  • Product Description
    Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)
  • Manufacturer
    Hamilton Co

Manufacturer

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