FDA Medical Device Recalls (openFDA)
SCC Soft Computer: 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.
- Recall number
- Z-0364-2011
- Recalling firm
- SCC Soft Computer
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-06-01
- Posted
- 2010-11-15
- Terminated
- 2012-07-16
- Reason
- 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.
- Root cause
- Software design
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Version 3.1.4.x
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000307651
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28