Recall Z-1546-2014 ยท GJS Test, Time, Prothrombin
Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic us
| Date | May 8, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. |
| Root cause | Under Investigation by firm |
| Action | Alere sent an Urgent: Medical Device Recall letter dated April 16, 2014 via fax, email or direct mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use, return remaining inventory to Alere, and complete the provided verification form to acknowledge receipt of the recall notice. For questions contact Alere Technical Service by phone at 844-292-5373 or by E-mail at INRatio.Notification@alere.com. UPDATED: On 05/06/2014, Alere issued a press release on this recall to the consumer/public level. The press release, dated May |
| Quantity | Estimated 99,795 Total units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092987 | INRATIO/INRATIO2 TEST STRIPS Biosite Incorporated, Jun 11, 2010 |