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 in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
This recall has been terminated (originally issued May 9, 2014).
- Company
- Scc Soft Computer
- Recall Initiated
- January 29, 2014
- Posted
- May 9, 2014
- Terminated
- November 3, 2014
- Recall Number
- Z-1573-2014
- Quantity
- 1
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in IL.
Lot / Code Info
SA HIS version 4.0.7.0
Root Cause
Software design
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.
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