FDAFDA · Food and drugs·Recall number Z-1573-2014
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.
Published May 21, 2014 · Recall initiated: January 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- SCC Soft Computer
- Distributor
- Distributed in IL.
- Lot
- SA HIS version 4.0.7.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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