INRatio Monitors - 0100004 Alere INRatio PT/INR System recall: Labeling Error
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio…
Why was INRatio Monitors - 0100004 Alere INRatio PT/INR System 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: 0100004, 0100007, and 0100137.
- Product
- INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio…
- 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)