SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used
FDA device recall Z-1573-2014 · posted 2014-05-09 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- Reason for recall
- When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.
- Action taken
- On 2/10/2014 SCC Soft Computer used a proprietary task management system to send a Correction Communication to the consignee with the affected software. The letter identifies the product, problem and corrective actions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 1
- Distribution
- Distributed in IL.
- Date initiated
- 2014-01-29
- Date posted
- 2014-05-09
- Date terminated
- 2014-11-03
- Location
- Clearwater, FL
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