Events

Recall of Device Recall Drugs of Abuse Screen

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

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
    60980
  • Event Risk Class
    Class 2
  • Event Number
    Z-1130-2012
  • Event Initiated Date
    2012-01-04
  • Event Date Posted
    2012-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106984
  • 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, barbiturate - Product Code DIS
  • Reason
    Alere san diego received a rise in customer complaints regarding false positive barbiturates (bar) results on the triage drugs of abuse panel plus tca.
  • Action
    Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.

Device

Device Recall Drugs of Abuse Screen
  • Model / Serial
    Part 90008: lot 259403 exp 02/03/13, lot 267081 exp 05/08/13 Part 92000: lots 254662, 255830, 257527, 262143 with exp 01/06/13; lots 259628, 259954 with exp 02/03/13 Part 92002: lot 234295 exp 02/03/13
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
  • Product Description
    Product Brand Names: Triage¿ Drugs of Abuse Panel 8 Test Kit (K924476), Triage¿ Drugs of Abuse || Panel Plus TCA (K973784), & Triage¿ Drugs of Abuse Panel Plus PPX (K014247) || Model Number: 90008, 92002, & 92000 || Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices || in a labeled kit box. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, || ASCENDTM MULTIMMUNOASSAY¿ (AMIATM). Each AMIATM assay is a competitive binding immunoassay || in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for || antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the || Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a || zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the || unbound conjugate and clear the background. Test results are visually read. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Manufacturer Address
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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