Recall Z-0938-05 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory with Lab Access Results application for versions 5.3 and later.
| Date | Jun 28, 2005 (initiated May 13, 2005) |
| Status | Terminated |
| Reason | Software anomaly may rarely allow modification of previously reported specimen results. |
| Root cause | Other |
| Action | Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch. |
| Quantity | 258 |
| Distribution | Nationwide and United Kingdom, Ireland, Denmark, Canada, 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.