Events

Recall of Device Recall NucliSensEasy Q Incubator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomerieux, 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
    28435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0735-04
  • Event Initiated Date
    2004-02-26
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31890
  • 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
    Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
  • Reason
    Instrument malfunction. electrical short circuit may occur resulting in damage or a fire hazard.
  • Action
    This correction is being handled as an instrument repair (rework) by bioMerieux Field Service; therefore no communication has been sent to the customer sites. The repair involves heat sink replacement or use of insulating tape on the rear side of the keypad.

Device

Device Recall NucliSensEasy Q Incubator
  • Model / Serial
    Catalog (or Product) number 285204, Serial Number 36061, 36065 and 36068
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CT, MD, MT
  • Product Description
    NucliSens¿Easy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).
  • Manufacturer
    Biomerieux, Inc.

Manufacturer

Biomerieux, Inc.
  • Manufacturer Address
    Biomerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA