Device product
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
Z-0880-2015
Product summary
- Event
- Event 69964
- Status
- Terminated
- Classification
- Class I
- Quantity
- 77,342 units (12 test strips/box) and 308,947 units (48 test strips/box)
- Official record key
device-enforcement:Z-0880-2015
Official wording
Reason: 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.
Code information: All lots of part numbers: 0100071 and 0100139.
Distribution pattern: Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Derived failure modes
-
Unknown
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.