Recall Z-0088-06 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory version 6.1 - Microbiology Module
| Date | Oct 22, 2005 (initiated Sep 29, 2005) |
| Status | Terminated |
| Reason | Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000. |
| Root cause | Other |
| Action | Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product. |
| Quantity | 67 |
| Distribution | Nationwide and Canada, Denmark, Emirates, 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.