Alere Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips

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 Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips

05/06/2014 03:34 PM EDT

WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This action is a result of complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

. 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 · 800-439-1420