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, F
FDA device recall Z-0344-2011 · posted 2010-11-10 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 31
- Distribution
- Nationwide Distribution - US and Puerto Rico.
- Date initiated
- 2010-02-16
- Date posted
- 2010-11-10
- Date terminated
- 2012-07-17
- Location
- Clearwater, FL
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