Recall Z-0736-04 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Instrumentation Laboratory Co.
ACL Futura Instrument Analyzer
| Date | Jul 20, 2004 (initiated Mar 4, 2004) |
| Status | Terminated |
| Reason | Software may cause instrument to omit step causing reagent carrover which may effect patient test result |
| Root cause | Other |
| Action | Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation. |
| Quantity | 1450 units |
| Distribution | Florida Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951891 | ACL FUTURA COAGULATION SYSTEM Instrumentation Laboratory CO, Nov 3, 1995 |