Recall Z-1093-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
| Date | Aug 7, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment. |
| Root cause | Other |
| Action | Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER. |
| Quantity | 157 |
| Distribution | Nationwide and to United Kingdom, Ireland, Canada, Denmark, 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.