PerkinElmer Health Sciences, Inc. recalls Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is…

Recall date

December 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0902-2017

FDA classification

Class II

Brand / firm

PerkinElmer Health Sciences, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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