Recall Z-1243-06 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
| Date | Jul 27, 2006 (initiated Oct 27, 2004) |
| Status | Terminated |
| Reason | Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon. |
| Root cause | Other |
| Action | Consignees were notified and the products were corrected by the firm. |
| Quantity | 4 |
| Distribution | Product was distributed to 4 clients, two in the United States and two in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.