Recall Z-0880-2015 ยท GJS Test, Time, Prothrombin
Alere San Diego, Inc.
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 seco
| Date | Jan 3, 2015 (initiated Dec 5, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to: -Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the pati |
| Quantity | 77,342 units (12 test strips/box) and 308,947 units (48 test strips/box) |
| Distribution | Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020679 | INRATIO Hemosense, Inc., May 6, 2002 |
| K021923 | INRATIO SELF-TEST Hemosense, Inc., Oct 24, 2002 |
| K072727 | INRATIO 2 PT MONITORING SYSTEM Hemosense, Inc., Oct 26, 2007 |
| K092987 | INRATIO/INRATIO2 TEST STRIPS Biosite Incorporated, Jun 11, 2010 |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP Alere San Diego, Inc (Formally Biosite Incorporate, May 1, 2012 |