Events

Recall of Cannabinoids Intercept Micro Plate EIA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OraSure Technologies, 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
    49562
  • Event Risk Class
    Class 3
  • Event Number
    Z-0481-2009
  • Event Initiated Date
    2008-09-08
  • Event Date Posted
    2008-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73814
  • 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
    Cannabinoid test system. - Product Code LDJ
  • Reason
    Readings, high: intermittent high absorbance readings. for further information, please contact the firm at 610-882-1820.
  • Action
    On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.

Device

Cannabinoids Intercept Micro Plate EIA

Manufacturer

OraSure Technologies, Inc.
  • Manufacturer Address
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Manufacturer Parent Company (2017)
    OraSure Technologies, Inc.
  • Source
    USFDA