SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Recall Z-0488-2012 · Posted 2012-01-11
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-05-03
Date Terminated2013-08-07
Product Quantity220
Reason for Recall
On 05/03/2011, SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected
Firm Action
SCC Soft Computer sent a "CORRECTION COMMUNICATION" notification letter to all affected customers. The letter describes the product, Risk-to-Health notification task, potential hazard, and corrective action. The customers were asked to acknowledge receipt of the task and grant permission for SCC to make the required and recommended changes. For any questions, call (727) 789-0100.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the 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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