Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator

Recalling company

Greiner Bio-One North America, Inc.

Product

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)

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 19, 2025

Reported

Nov 26, 2025

Distribution

U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None

Status

Ongoing

Quantity

1,980,000

Lot / codes

Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061

Company location

Monroe, NC

Recall type

Voluntary: Firm initiated

Recall number

Z-0571-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0571-2026 in the FDA Enforcement Report. Also see FDA recall press releases.