Recall Z-1573-2014— SCC Soft Computer
Class II · Terminated
Class II FDA medical device recall by SCC Soft Computer, initiated 2014-01-29, terminated 2014-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- SCC Soft Computer
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-29
- Terminated
- 2014-11-03
- Firm location
- Clearwater, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.