Class II — Potential Health Hazard

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

NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000 Recalled by Northeast Laboratory Services, Inc. Due to Product marketed without a 510 (k)

Date: December 21, 2015
Company: Northeast Laboratory Services, 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 Northeast Laboratory Services, Inc. directly.

Affected Products

NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Quantity: 9300

Why Was This Recalled?

Product marketed without a 510 (k)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Northeast Laboratory Services, Inc.

Northeast Laboratory Services, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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