SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.
This recall has been terminated (originally issued November 10, 2010).
- Company
- Scc Soft Computer
- Recall Initiated
- February 16, 2010
- Posted
- November 10, 2010
- Terminated
- July 17, 2012
- Recall Number
- Z-0344-2011
- Quantity
- 31
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.
Distribution
Nationwide Distribution - US and Puerto Rico.
Lot / Code Info
Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
Root Cause
Software design
Action Taken
Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the 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.