Events

Recall of Device Recall BSure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Harmony Brands Llc.

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
    31500
  • Event Risk Class
    Class 2
  • Event Number
    Z-0909-05
  • Event Initiated Date
    2005-03-25
  • Event Date Posted
    2005-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38013
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Reason
    Lack of assurance of safety and efficacy; products are from unknown sources.
  • Action
    Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.

Device

Device Recall BSure
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States .
  • Product Description
    B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
  • Manufacturer
    Harmony Brands Llc

Manufacturer

Harmony Brands Llc
  • Manufacturer Address
    Harmony Brands Llc, 13240 Capital St, Oak Park MI 48237-3159
  • Source
    USFDA