Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Prof

FDA device recall Z-1546-2014 · posted 2014-05-08 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

Reason for recall

Test Strips may report an inaccurately low INR result. Several patients 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.

Action taken

Alere sent an Urgent: Medical Device Recall letter dated April 16, 2014 via fax, email or direct mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use, return remaining inventory to Alere, and complete the provided verification form to acknowledge receipt of the recall notice. For questions contact Alere Technical Service by phone at 844-292-5373 or by E-mail at INRatio.Notification@alere.com. UPDATED: On 05/06/2014, Alere issued a press release on this recall to the consumer/public level. The press release, dated May 6, 2014, announced Alere Inc.s voluntary Class I recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). The press release also stated the following information: reason for recall, any adverse event reports, reason for the adverse event reports , root cause not yet determined, notified customers to immediately STOP using the product, product description with codes, contact information, FDA MedWatch information and about Alere and About the Alere INRation2 PT/INR Professional Monitoring System.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GJS

Quantity affected

Estimated 99,795 Total units

Distribution

US Nationwide Distribution

Date initiated

2014-04-16

Date posted

2014-05-08

Date terminated

2017-07-19

Location

San Diego, CA

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