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U.S. Department of Health and Human Services

Class 2 Device Recall SA BASE with SoftLab Version 3.1.4.x.

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 Class 2 Device Recall SA BASE with SoftLab Version 3.1.4.x.see related information
Date Initiated by FirmJune 01, 2010
Date PostedNovember 15, 2010
Recall Status1 Terminated 3 on July 16, 2012
Recall NumberZ-0364-2011
Recall Event ID 56865
Product Classification Calculator/Data Processing Module for Clinical Use - Product Code JQP
ProductSA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
Code Information Version 3.1.4.x
Recalling Firm/
Manufacturer		 SCC Soft Computer
Manufacturer Reason
for Recall		Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated to a patient record.
FDA Determined
Cause 2		Software design
ActionClients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.
Quantity in Commerce40
DistributionWorldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
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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