Recall Z-1246-06 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory Co.
HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO
| 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 | 8 mL: 10,473; 20 mL: 5110 (all Domestic) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043184 | HEMOSIL RECOMBIPLASTIN Instrumentation Laboratory CO, Dec 22, 2004 |