Class II — Potential Health Hazard

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

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Recalled by Greiner Bio-One North America, Inc. Due to Some of the Vacuette¿ CAT Serum Separator Clot...

Date: August 19, 2025
Company: Greiner Bio-One North America, Inc.
Status: Ongoing
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 Greiner Bio-One North America, Inc. directly.

Affected Products

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

Quantity: 1,980,000

Why Was This Recalled?

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

Where Was This Sold?

This product was distributed to 28 states: AL, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, ME, MD, MA, MI, MS, MO, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WY

Affected (28 states)Not affected

About Greiner Bio-One North America, Inc.

Greiner Bio-One North America, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

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