FDA Medical Device Recalls (openFDA)
SCC Soft Computer: 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.
- Recall number
- Z-0344-2011
- Recalling firm
- SCC Soft Computer
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-02-16
- Posted
- 2010-11-10
- Terminated
- 2012-07-17
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 31
- Distribution
- Nationwide Distribution - US and Puerto Rico.
- Lot, serial or model codes
- Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000307651
- Firm city
- Clearwater
- Firm state
- FL
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06