Recall Z-1127-2007 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
| Date | Aug 7, 2007 (initiated Jun 19, 2007) |
| Status | Terminated |
| Reason | ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. |
| Root cause | Other |
| Action | 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. |
| Quantity | 94 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063679 | ACL TOP Instrumentation Laboratory CO, Jan 12, 2007 |