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

Fresenius Kabi hit with Class I notification for recall

This article was originally published in Clinica

Executive Summary

The US FDA has branded Fresenius Kabi’s recall of its red blood cell set as a Class I notice. Fresenius initiated the recall on 18 October, telling its customers to discontinue use of the product after it discovered that the device removed more red blood cells than intended, causing haemodilution. The set is used on the AS104 blood cell separator system. The set is designed to for the depletion or exchange of red blood cells during therapeutic aphaeresis procedures, when blood is removed from the patient and separated into its different components. A total of 255 units are affected by the recall, all manufactured between 1 October 2007 and 30 July 2010.

You may also be interested in...



Alere aided by professional diagnostics sales in fourth quarter

Alere’s professional diagnostics business helped the firm record overall revenue growth in the fourth quarter of 2010, offsetting a fall in influenza-based sales in North America.

Integra and Stout to work on expandable interbody device

Integra LifeSciences has gained exclusive worldwide rights from Stout Medical to develop and commercialise an expandable interbody fusion device.

Gen-Probe eyes portfolio expansion to help boost molecular diagnostics credentials

Gen-Probe recently launched its Panther automated molecular diagnostics system in Europe with the aim of bringing another dimension to its product portfolio. Joseph Harvey met the firm’s CEO, Carl Hull, at the launch of the product in Frankfurt to find how high the firm has set its sights in the molecular diagnostics sector and how it is going to achieve its goals

Topics

UsernamePublicRestriction

Register

LL010986

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