Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

 

Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System

07/12/2016 10:27 AM EDT

WALTHAM, Mass. - Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc. (NYSE:ALR) will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? Please visit subscriberhelp.govdelivery.com
• Other inquiries? webmail@oc.fda.gov

---

This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)