Alere INRatio Replacement Monitor recall
Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of…
Why was Alere INRatio Replacement Monitor recalled?
Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 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¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots All Serial Numbers
- Product
- Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of…
- Recalling firm
- Alere San Diego, Inc.
- Distribution
- Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
- Recall date
- August 31, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)