Recall Z-1217-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
| Date | Sep 11, 2003 (initiated Jul 22, 2003) |
| Status | Terminated |
| Reason | Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. |
| Root cause | Other |
| Action | Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003. |
| Quantity | 171 |
| Distribution | Nationwide and to United Kingdom, Canada, Denmark, Ireland, 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.