Recall Z-0238-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
| Date | Jul 20, 2004 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients. |
| Root cause | Other |
| Action | A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall. |
| Quantity | 125 |
| Distribution | Nationwide, Canada, Saudi Arabia, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.