Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1252-06

SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results...

SCC Soft Computer / initiated 2001-01-09 / Terminated

SCC Soft Computer began a recall of SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3 on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1252-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
Product code
JQP Calculator/Data Processing Module, For Clinical Use
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.
FDA 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 in commerce
171
Distribution
Nationwide and Canada.
Product codes and lots
Releases 1.2, 2.1, and 2.3