Date Initiated by Firm | January 09, 2001 |
Date Posted | July 26, 2006 |
Recall Status1 |
Terminated 3 on July 19, 2010 |
Recall Number | Z-1252-06 |
Recall Event ID |
35375 |
Product Classification |
pathology lab software - Product Code JQP
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Product | SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3 |
Code Information |
Releases 1.2, 2.1, and 2.3 |
Recalling Firm/ Manufacturer |
SCC Soft Computer 34350 US Highway 19 N Palm Harbor FL 34684-2149
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Manufacturer 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 Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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