SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1,
FDA device recall Z-1252-06 · posted 2006-07-26 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 171
- Distribution
- Nationwide and Canada.
- Date initiated
- 2001-01-09
- Date posted
- 2006-07-26
- Date terminated
- 2010-07-19
- Location
- Palm Harbor, FL
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