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U.S. Department of Health and Human Services

Class 2 Device Recall SoftCytogenetics

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 Class 2 Device Recall SoftCytogeneticssee related information
Date Initiated by FirmMarch 31, 2021
Create DateJuly 20, 2021
Recall Status1 Terminated 3 on February 14, 2023
Recall NumberZ-2098-2021
Recall Event ID 88105
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductSoftCytogenetics
Code Information Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
Recalling Firm/
Manufacturer		 Soft Computer Consultants, Inc.
5400 Tech Data Dr
Clearwater FL 33760-3116
For Additional Information ContactTechnical Support 24/7
800-763-8522
Manufacturer Reason
for Recall		Software is given wrong results going out to HIS on test that had reruns.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionDear SoftCytogentics Customer, The purpose of this letter is to advise you that SCC is voluntarily recalling SoftCytogenetics 4.1.11.20 and 4.1.12.11. There are software errors in these versions which SCC has designated to pose a potential risk-to-health issue. Reason for the Voluntary Recall: This task is to inform you of functionality in SoftCytogentics which SCC has designated to be a potential patient Risk-to-Health issue. For clients using Outbound Result Reporting with Resulting Profiles including Test Chapter macros, for cases that had multiple runs for reportable fields included to the Test Chapter macro, results from incorrect run may be sent outbound in HL7 message. Risk to Patient Care: When the results for test are processed with more than one run, and test uses the outbound reporting configuration of Resulting Profile* with Test Result macro added within, then some of results related to last reportable run can be sent outbound with values coming from any of the previous runs. These values are picked randomly from the previous runs. YOUR FACILITY DOES NOT CURRENTLY USE THIS CONFIGURATION. A hot fix would be required if you decide to implement this result reporting configuration prior to the next patch. Corrective Action: This issue will be corrected in the next software patch. Actions to be taken by the Customer/User: Please acknowledge receipt of this task and choose one of the following options: Workflow or functionality not used Agree to use alternative working solution Request hot fix if you decide to implement this result reporting configuration prior to the next patch.
Quantity in Commerce5
DistributionUS Nationwide Distribution in the states of CA, FL, MN and NJ.
Total Product Life CycleTPLC Device Report
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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