Device product
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
Z-0902-2017
Product summary
- Event
- Event 75817
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-0902-2017
Official wording
Reason: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Code information: Software Version 1.0
Distribution pattern: Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
Derived failure modes
-
Unknown
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.