Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring syste
FDA device recall Z-2357-2016 · 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 Systems (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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INRATIO 2 PT MONITORING SYSTEM (K072727) | Hemosense, Inc. | 2007-10-26 |