Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
FDA device recall Z-1127-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.
- Action taken
- Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 94
- Distribution
- Nationwide.
- Date initiated
- 2007-06-19
- Date posted
- 2007-08-07
- Date terminated
- 2012-05-23
- 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 (K063679) | Instrumentation Laboratory CO | 2007-01-12 |