Events

Recall of Device Recall Medplus ER Drug Screen Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Biotech 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
    35656
  • Event Risk Class
    Class 2
  • Event Number
    Z-1315-06
  • Event Initiated Date
    2005-05-31
  • Event Date Posted
    2006-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46564
  • 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
    drug screen test - Product Code LCM
  • Reason
    The firm has discovered that a number of distributed devices of the medplus er drug screen test may be incorrectly assembled which may give incorrect results. the product is an in vitro test for rapid detection of various drugs such as amphetamines, barbiturates, phencyclidine, cocaine, methamphetamine, tricyclic antidepressants, morphine, tetrahydrocannabinol, & benzodiazepines in human urine.
  • Action
    Recall notifications that describe the problem, dated May 31,2005, were sent via fax. Customers were instructed to block all stock of affected lots in their warehouse, contact their primary consignees and advise them to discontinue use immediately and dispose any unused materials. A faxback form was used to communicate to the recalling firm the quantity blocked and disposed of. Arrangements were made for providing replacement product.

Device

Device Recall Medplus ER Drug Screen Test
  • Model / Serial
    Lot Numbers Affected: 85699 and 85671
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide (distributors in KS and OR).
  • Product Description
    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
  • Manufacturer
    Applied Biotech Inc

Manufacturer

Applied Biotech Inc
  • Manufacturer Address
    Applied Biotech Inc, 10237 Flanders Ct, San Diego CA 92121-2901
  • Source
    USFDA