Recall of Device Recall Clearview iFOB Test Cassettes (50 Test)

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

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
    58407
  • Event Risk Class
    Class 2
  • Event Number
    Z-2109-2011
  • Event Initiated Date
    2011-03-21
  • Event Date Posted
    2011-04-28
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-03-07
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Reagent, occult blood - Product Code KHE
  • Reason
    Potential for false negatives test results and negative/faint positive controls.
  • Action
    Alere sent a Voluntary Product Recall letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to indicate zero on the attached Recall Reply Form, sign, and fax to 1-877-877-0147, if they have no remaining product. For any remaining product customers were instructed to discontinue use and indicate the quantity of kits in the attached Recall Reply Form so that the firm can arrange for them to receive credit. Customers were instructed to destroy any affected units at their site. For any further distribution of product, customers will need to be contacted. Physicians and hospitals were advised to retest patients with negative results. Questions relating to this Voluntary Product Recall call 1-877-597-9586.

Device

  • Model / Serial
    Lot Numbers:  0626810 0808110
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Clearview¿ iFOB, Clearview¿ - Clearview iFOB Test Cassettes (50 Test) || Immunochemical Fecal Occult Blood Cassette Test || Product Part Number: || 8115KCV (25 Test Kit ), || Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Alere North Americal, 30 S Keller Rd Ste 100, Suite 100, Orlando FL 32810-6297
  • Manufacturer Parent Company (2017)
  • 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