Recall Z-0881-2015 ยท GJS Test, Time, Prothrombin
Alere San Diego, Inc.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, a
| 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 | 231,967 Test Systems including Monitors |
| Distribution | Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East. |
| FDA record | Open on fda.gov |