Events

Recall of Device Recall Microlab F.A.M.E. reagent containers

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
    38352
  • Event Risk Class
    Class 2
  • Event Number
    Z-1169-2007
  • Event Initiated Date
    2007-03-29
  • Event Date Posted
    2007-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53477
  • 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
    reagent containers - Product Code JQW
  • Reason
    Some product containers may be leaking.
  • Action
    The firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.

Device

Device Recall Microlab F.A.M.E. reagent containers
  • Model / Serial
    Part number 148482, lot codes 34906, 20207, 30307, 30407, 20507, 30607, 20707, 40707.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.
  • Product Description
    Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
  • Manufacturer
    Hamilton Co

Manufacturer

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