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 Recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY Due to Potential for errors in patient results generated by...

Date: March 7, 2017
Company: PerkinElmer Life and Analytical Sciences, Wallac, OY
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 Life and Analytical Sciences, Wallac, OY directly.

Affected Products

Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

Quantity: 29

Why Was This Recalled?

Potential for errors in patient results generated by the Specimen Gate Laboratory Software.

Where Was This Sold?

This product was distributed to 23 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA

Affected (23 states)Not affected

About PerkinElmer Life and Analytical Sciences, Wallac, OY

PerkinElmer Life and Analytical Sciences, Wallac, OY has 9 total recalls tracked by RecallDetector.

Related Recalls

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