Date Initiated by Firm |
March 31, 2021 |
Create Date |
July 19, 2021 |
Recall Status1 |
Terminated 3 on April 15, 2022 |
Recall Number |
Z-2093-2021 |
Recall Event ID |
88095 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
|
Product |
SoftGenomics version 4.1.15.6
SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting. |
Code Information |
Version 4.1.15.6 |
Recalling Firm/ Manufacturer |
Soft Computer Consultants, Inc. 5400 Tech Data Dr Clearwater FL 33760-3116
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For Additional Information Contact |
Technical Support 24/7 800-763-8522
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Manufacturer Reason for Recall |
Software showing wrong results reported, PDF not match HIS.
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FDA Determined Cause 2 |
Software Design Change |
Action |
The firm sent an " URGENT: MEDICAL DEVICE RECALL" letter dated 6/2/2021 to its sole consignee of the correction on 06/02/2021 by mail. The letter described the product, problem and actions to be taken. The consignee was instructed to do the following:
Acknowledge receipt of this letter in the TMS task
Give permission to load Hot Fix on Test environment
Perform validation activities to completion
Acknowledge Hot Fix has been moved to Live environment and is working as expected
Type of action by Company: All clients on affected lines of software have been notified of the recall. SCC will provide Hot Fixes for all affected lines that will be delivered to all affected clients. Until the software correction is delivered, clients have been informed of an alternative workflow to avoid the problem.
The firm provided information on a software update performed on 03/31/2021 and stated that, "Hot Fix has already been delivered."
If you have any further questions, Please call 1-800-763-8522 (Technical Support 24/7). |
Quantity in Commerce |
1 |
Distribution |
US Distribution to: CA only |
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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