Recall Z-0364-2007 ยท GJS Test, Time, Prothrombin
Abbott Point of Care Inc.
i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Canada
| Date | Jan 23, 2007 (initiated Dec 12, 2006) |
| Status | Terminated |
| Reason | Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges. |
| Root cause | Other |
| Action | Customers were notified by letter sent by regular mail on 12/13/2006. |
| Quantity | 14,045 boxes of 24 |
| Distribution | Nationwide to hospitals and health care facilities |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020355 | I-STAT PROTHROMBIN TIME TEST I-Stat Corporation, May 14, 2002 |