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, 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
    67529
  • Event Risk Class
    Class 2
  • Event Number
    Z-1214-2014
  • Event Initiated Date
    2014-02-05
  • Event Date Posted
    2014-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125676
  • 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, methadone - Product Code DJR
  • Reason
    Alere san diego, inc. is initiating a recall of the alere triage¿ tox drug screen, catalog number 94400, lots w56013b and w56035b because alere's investigation has shown that these lots have a frequency of false negative results for pcp (phencyclidine) that is higher than the frequency shown in the package insert. if you have questions about previously reported results.
  • Action
    Alere San Diego, Inc. sent out recall notification letters to customers via direct mail or email. The letter, dated February 3, 2014, titled "URGENT MEDICAL DEVICE RECALL", provided customers the following information: product description with codes, reason for recall, impact, contact information and customer/distributor required actions. A Customer/Distributor Verification Form was provided. Customers were instructed to discontinue use and discard the affected lots. Alternately, if you elect to continue to use the product customers must verify if it will not be used to report results for PCP. Customers were instructed to return the Customer Verification Form by fax to 858-805-8457 with the amount of product they have for credit. The information should be shared with their laboratory staff and the notification should be retained as part of their laboratory Quality System documentation. If the product has been forwarded customers were instructed to provide a copy of the letter to them. Customers with questions were instructed to contact Alere San Diego, Inc. at 877-308-8287 or email Triage.Support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.

Device

Device Recall Drugs of Abuse Screen
  • Model / Serial
    Catalog Number 94400, Lots W56013B and W56035B
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.
  • Product Description
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. || 25 individually pouched devices in a labeled kit box. || Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 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