Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Specimen Gate Laboratory 5002-0180 Recalled by PerkinElmer Health Sciences, Inc. Due to Issue may cause eReports to consume an excessive...

Date: December 1, 2016
Company: PerkinElmer Health Sciences, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PerkinElmer Health Sciences, Inc. directly.

Affected Products

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

Quantity: 21

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 12 states: AZ, CO, FL, GA, IL, KY, MA, MI, NV, NJ, OH, SC

Affected (12 states)Not affected

About PerkinElmer Health Sciences, Inc.

PerkinElmer Health Sciences, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report