Recall Z-0737-04 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Instrumentation Laboratory Co.
ACL Advance 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 | 760 units |
| Distribution | Florida Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002400 | MODIFICATION OF ACL ADVANCE Instrumentation Laboratory CO, Aug 30, 2000 |