Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1243-06

Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for...

SCC Soft Computer / initiated 2004-10-27 / Terminated

SCC Soft Computer began a recall of 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... on . The reason FDA records is "Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1243-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
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.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
FDA root cause
Other
Action
Consignees were notified and the products were corrected by the firm.
Quantity in commerce
4
Distribution
Product was distributed to 4 clients, two in the United States and two in Canada.
Product codes and lots
Releases 2.3.0 and 4.3.7.