SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
FDA device recall Z-0364-2011 · posted 2010-11-15 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 40
- Distribution
- Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
- Date initiated
- 2010-06-01
- Date posted
- 2010-11-15
- Date terminated
- 2012-07-16
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