FDAFDA · Food and drugs·Recall number Z-0902-2017
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
Published January 4, 2017 · Recall initiated: December 1, 2016
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
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Distributor
- 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
- Lot
- Software Version 1.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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