Recall Z-1252-06 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
| Date | Jul 26, 2006 (initiated Jan 9, 2001) |
| Status | Terminated |
| Reason | The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report. |
| Root cause | Other |
| Action | The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory. |
| Quantity | 171 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.