Z-1573-2014 Class II Terminated
FDA device recall Z-1573-2014 was initiated by SCC Soft Computer on January 29, 2014 and is designated Class II. 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 … The recall status is terminated (terminated November 3, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- January 29, 2014
- Termination Date
- November 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
Distributed in IL.
Code Information
SA HIS version 4.0.7.0