Events

Recall of Device Recall Triage Drugs of Abuse Panel

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
    50689
  • Event Risk Class
    Class 2
  • Event Number
    Z-1088-2009
  • Event Initiated Date
    2008-11-06
  • Event Date Posted
    2009-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75998
  • 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
    Amphetamine Enzyme Immunoassay - Product Code DKZ
  • Reason
    The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive pcp results has exceeded their post market surveillance thresholds for customer complaints in the field. in addition, the firm has been able to reproduce false positive results reported by customers and as a result.
  • Action
    Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days.

Device

Device Recall Triage Drugs of Abuse Panel
  • Model / Serial
    Lot/Unit Codes: 186625
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and country of Canada.
  • Product Description
    Triage Drugs of Abuse Panel, Model Number: 95000. || Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
  • 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