Events

Recall of Quality Control Material

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
    66394
  • Event Risk Class
    Class 3
  • Event Number
    Z-0053-2014
  • Event Date Posted
    2013-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122244
  • 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 mixture control materials - Product Code DIF
  • Reason
    Alere san diego, inc. initiated a voluntary recall of alere triage tox drug screen control 1 (pn 94413, lot c2681a) because the code chip that was provided with this lot causes the control to fail when run in the qc sample mode using alere triage tox drug screeen products. the alere triage tox drug screen test devices and patient results are not affected.
  • Action
    Alere San Diego, Inc. sent an Urgent Medical Device Notice dated September 23, 2013, to all affected customers via FedEx and outside US (OUS) consignees on September 24, 2013, via email. The customer notification letter titled "URGENT MEDICAL DEVICE NOTICE", informed customers of the recall, product description with part number and lot code (Alere Triage¿ TOX Drug Screen Control 1 PN 94413 Lot C2681A), reason for recall and impact (The purpose of the letter was to inform customers that the CODE CHIP" that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage¿ TOX Drug Screen products. Customers were instructed to discontinue use of and discard the CODE CHIP contained within the Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A kit box. Customers were also instructed to provide a copy of the notice to their customers and instruct them to contact Alere for a replacement code chip. Customers were asked to complete and fax the enclosed Verification Form to confirm their receipt of the notice. Customers with questions were instructed to contact: (Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121, U.S.A. Phone: 877 308 8287 FAX: 858 805 8457 E-mail: Responses.ts@alere.com). For questions regarding this recall call 858-805-2000, ext 3015.

Device

Quality Control Material
  • Model / Serial
    Part Number 94413. Lot Number C2681A.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
  • Product Description
    Alere Triage¿ TOX Drug Screen Control 1 || Product Generic Name: Quality Control Material || Description of the product: || Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment || of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control || procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures || described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results || obtained for the controls are to be compared with the assigned values given on the Expected Values Card, || accompanying the package insert, to determine if the procedure is within control limits. || Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of || human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. || 510(k)/IDE/PMA number: K060788 || Type of Packaging: 5 vials per level in a labeled kit box. || Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
  • 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