Events

Safety Alert Or Field Safety Notices for Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/012
  • Event Number
    CON249673
  • Event Date Posted
    2013-03-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON249673?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Health canada (the canadian regulatory authority for medical devices) has suspended sale of these kits in canada due to concerns about the manufacturer’s quality systems – see: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.Php health canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device. the mhra has not received any reports of adverse incidents in the uk involving these devices. the product is currently still available for use in the uk the mhra is continuing to monitor this situation.
  • Action
    Users should report any incidents of false results involving these products to the MHRA and the supplier, to enable the MHRA to monitor the situation in the UK. Note: the MHRA will consider the need to issue further advice based upon information received from UK users. Healthcare personnel treating patients based on results from test strips. Healthcare personnel using, supplying, supervising, quality assuring or distributing these test strips.

Device

Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opi...
  • Model / Serial
  • Product Description
    "Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by: IND Diagnostics Inc, Canada Alere International Ltd Barrier Healthcare Ltd E-Pharm Ltd The table below lists test strips that have been supplied in the UK between January 2011 and March 2013 Manufacturer Device Type Device Name IND Diagnostics Urinalysis Reagent Test Strips Urinalysis Reagent Test Strips IND Diagnostics HCG Pregnancy Test Indicator One-Step Urine Pregnancy Test (Cassette Format) Indicator One-Step Urine Pregnancy Test (Ministrip Format) Indicator One-Step Home Pregnancy Test (Midstream Format) Indicator One-Step Home Pregnancy Test (Mini-Midstream Format) IND Diagnostics FSH Menopause tests One Step FSH Menopause Test (Strip Format) One Step FSH Menopause Test (Cassette Format) One Step FSH Menopause Test  (Midstream Format) IND Diagnostics Opiates Test IND One Step Opiates Test Alere International Ltd. HCG Pregnancy test Axis Shield Pregnancy test dipstick and cassette Barrier Healthcare Ltd Urinalysis Reagent Test Strips DIA-CHECK Urinalysis Reagent Strips E-Pharm HCG Pregnancy Test PREGTEST (Strip format) PREGTEST (Cassette format) PREGTEST (Midstream format)"
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    MHRA