Events

Recall of MultiDrug iCup Drug Screen Test Cup

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosite 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
    52202
  • Event Risk Class
    Class 2
  • Event Number
    Z-0006-2010
  • Event Initiated Date
    2009-04-27
  • Event Date Posted
    2009-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82495
  • 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
    Enzyme immunoassay, amphetamine - Product Code DKZ
  • Reason
    The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
  • Action
    Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used. For further information, contact Biosite, Inc. using the following information: Biosite Incorporated, an Inverness Medical Company 9975 Summers Ridge Road San Diego, CA 92121 Phone: 1-877-441-7440, option 2 Fax: 1-858-695-7100 Email: productadvisory@invmed.com

Device

MultiDrug iCup Drug Screen Test Cup
  • Model / Serial
    Lot Numbers: DOA8080780, DOA8080781, DOA8080782, DOA8080783 and DOA8080784.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. || Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
  • Manufacturer
    Biosite Inc

Manufacturer

Biosite Inc
  • Manufacturer Address
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA