PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 4, 2017 Initiated: December 1, 2016 #Z-0902-2017

Product Description

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

Reason for Recall

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

Details

Units Affected
21
Distribution
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
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by PerkinElmer Health Sciences, Inc.. Units affected: 21.
Why was this product recalled? ▼
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 4, 2017. Severity: Moderate. Recall number: Z-0902-2017.

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