Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. 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.
This recall has been terminated (originally issued November 21, 2011).
- Company
- Scc Soft Computer
- Recall Initiated
- August 8, 2011
- Posted
- November 21, 2011
- Terminated
- November 22, 2013
- Recall Number
- Z-0261-2012
- Quantity
- 255
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0
Distribution
Worldwide Distribution - USA ( nationwide) and Canada.
Lot / Code Info
Versions: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
Root Cause
Software design
Action Taken
SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue. Each client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail. SCC recommended to the customer until Live on the correction avoid making edits in the instrument menu. For further questions please call (727) 789-0100.