Events

Recall of Device Recall Triad Alcohol Prep Pads

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
    59064
  • Event Risk Class
    Class 2
  • Event Number
    Z-2661-2011
  • Event Initiated Date
    2011-02-28
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100988
  • 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
    Test, time, prothrombin - Product Code GJS
  • Reason
    The recall of the triad group alcohol prep products is due to potential contamination of these products with the bacteria bacillus cereus, which could lead to life-threatening infections.
  • Action
    Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers. The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads. The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.

Device

Device Recall Triad Alcohol Prep Pads
  • Model / Serial
    Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following:  218494,220447,223941,223943,224250,224251,224770,224771,224772,225544,229364,229365, 229366,229367,229368,229369,229370,229371,235188,235189,236334,236335,236336,238868, 238869,239283,239418,239419,239595,243020,243021,243413,243414,243415,243416,243417, 243418,243855,243856,243857,243858,243859,243860,243861,243862,243863,243864,243865, 244432,245759,245760,245761,245762,245763,245764
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
  • Product Description
    0200086, Triad Alcohol Prep Pads, 100 box || 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or || Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; || 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- || Test System; || 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
  • 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