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PerkinElmer Health Sciences, Inc. recalls Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is
Recalled January 4, 2017 · FDA recall Z-0902-2017 · PerkinElmer Health Sciences
Hazard
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating. · FDA Class II
Units
21
Sold at
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
Description
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
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
Manufacturer(s)
PerkinElmer Health Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →