SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
FDA Recall Z-1252-06 · Posted 2006-07-26
Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2001-01-09
Date Terminated2010-07-19
Product Quantity171
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.