ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
FDA device recall Z-0915-05 · posted 2005-06-21 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
- Action taken
- Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 617 units
- Distribution
- Nationwide Canada
- Date initiated
- 2005-05-19
- Date posted
- 2005-06-21
- Date terminated
- 2006-12-06
- 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 |
|---|---|---|
| ACL TOP MODEL, TOP (K033414) | Instrumentation Laboratory CO | 2004-01-12 |
| MODIFICATION OF ACL ADVANCE (K002400) | Instrumentation Laboratory CO | 2000-08-30 |
| ACL FUTURA COAGULATION SYSTEM (K951891) | Instrumentation Laboratory CO | 1995-11-03 |