Recall Z-1247-06 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory Co.
Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preserva
| Date | Jul 18, 2006 (initiated Mar 7, 2006) |
| Status | Terminated |
| Reason | Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). |
| Root cause | Other |
| Action | "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter. |
| Quantity | 5 mL: 3870; 20 mL: 29,007 (all Domestic) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT Ortho Diagnostic Systems, Inc., Mar 12, 1993 |