HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20
FDA device recall Z-1246-06 · posted 2006-07-18 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- 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).
- Action taken
- "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 8 mL: 10,473; 20 mL: 5110 (all Domestic)
- Distribution
- Nationwide
- Date initiated
- 2006-03-07
- Date posted
- 2006-07-18
- Date terminated
- 2006-08-11
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOSIL RECOMBIPLASTIN (K043184) | Instrumentation Laboratory CO | 2004-12-22 |