Events

Recall of Inverness Medical BioStar Strep A OIA MAX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Binax, Inc. dba IMPD.

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
    51871
  • Event Risk Class
    Class 2
  • Event Number
    Z-1506-2009
  • Event Initiated Date
    2009-04-06
  • Event Date Posted
    2009-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81490
  • 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
    strep test in vitro diagnostic - Product Code GTZ
  • Reason
    Potential for false positive strep a results.
  • Action
    Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.

Device

Inverness Medical BioStar Strep A OIA MAX
  • Model / Serial
    All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09;  196278, 196279, 196280, and 196281, expire 06/30/09.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, || Product Code: 90003, in vitro diagnostic.
  • Manufacturer
    Binax, Inc. dba IMPD

Manufacturer

Binax, Inc. dba IMPD
  • Manufacturer Address
    Binax, Inc. dba IMPD, 10 Southgate Rd, Scarborough ME 04074
  • 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