medical Class II Updated 2017-01-04

PerkinElmer Health Sciences, Inc. recalls Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5

Recalled 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


Hazard / Issue

Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

Issued by

FDA

Affected States: CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY
Lot/Code Info: Software Version 1.0
View official government recall

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