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
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