PerkinElmer Health Sciences, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0902-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 1, 2016

Date Posted: January 4, 2017

Recall Number: Z-0902-2017

Event ID: 75817

Reason for Recall:

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

Status: Terminated

Product Quantity: 21

Code Information:

Software Version 1.0

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated