Recall Z-1007-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System, versions 5.2, 5.23 and 5.3
| Date | Jul 15, 2003 (initiated Jun 10, 2003) |
| Status | Terminated |
| Reason | Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations. |
| Root cause | Other |
| Action | Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality. |
| Quantity | 467 |
| Distribution | Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, Saudi Arabia, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.