Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPla
FDA device recall Z-1247-06 · 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
- 5 mL: 3870; 20 mL: 29,007 (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 |
|---|---|---|
| ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT (K925604) | Ortho Diagnostic Systems, Inc. | 1993-03-12 |