SA 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.
FDA Recall Z-0364-2011 · Posted 2010-11-15
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2010-06-01
Date Terminated2012-07-16
Product Quantity40
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.
Firm Action
Clients 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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