INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR recall: Labeling Error
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433…
Why was INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR recalled?
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
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 of part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A.
- Product
- INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 231,967 Test Systems including Monitors
- Distribution
- Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
- Recall date
- January 14, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)