Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System

FDA device recall Z-2354-2016 · posted 2016-08-19 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

Reason for recall

Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Action taken

Alere issued a press release on July 11, 2016. An Urgent Medical Device Letter dated July 26, 2016 was sent to affected customers on July 29, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to consult with their healthcare provider as soon as possible to transition to an alternate method of PT/INR testing and to contact the firm regarding return or disposal of unused product and obtaining device replacement from a different manufacturer. For questions contact the Alere INRatid1 Recall Hotline at 1-866-723-2535.

Root cause

Other

Status

Terminated

Product code

GJS

Distribution

Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colomb

Date initiated

2016-07-11

Date posted

2016-08-19

Date terminated

2017-07-20

Location

San Diego, CA

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