Events

Recall of Mega Diagnostics Ammonia/Alcohol Controls

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

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
    37254
  • Event Risk Class
    Class 3
  • Event Number
    Z-0743-2007
  • Event Initiated Date
    2006-09-20
  • Event Date Posted
    2007-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50199
  • 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
    Ammonia/Alcohol Controls - Product Code JIX
  • Reason
    Potential for microorganism growth in the alcohol standard and or unexpected qc changes in the ammonia portion of the ammonia/alcohol control product.
  • Action
    The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product

Device

Mega Diagnostics Ammonia/Alcohol Controls

Manufacturer

Mega Diagnostics
  • Manufacturer Address
    Mega Diagnostics, 2716 N Main St, Los Angeles CA 90031-3321
  • Source
    USFDA