Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

France withdraws two Bayer HIV tests:

This article was originally published in Clinica

Executive Summary

The French Healthcare Products Safety Agency, AFSSAPS, has withdrawn two of Bayer's HIV tests from the market. The decision is based on the grounds that the sensitivity results of the assays - Serodia HIV and Serodia HIV 1/2 - were borderline and that it would be impossible to improve their performance. The tests are manufactured by Japan's Fujirebio and marketed in France by Bayer. The German company is not aware of the same products being banned in other countries in Europe. France banned six other HIV tests in June.

You may also be interested in...



COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

Warning Letter Close-Outs – November 2020

The US Food and Drug Administration posted two device-related closeout letters in November.

Jazz And PharmaMar’s Zepzelca Hits Buffers In ATLANTIS Study

Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.

Topics

UsernamePublicRestriction

Register

OM006664

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel