Greiner Bio-One North America, Inc.: Device Recall

Recall Details

Recall Number

Z-0571-2026

Classification

Class II

Product Type

Device

Recalling Firm

Greiner Bio-One North America, Inc.

Status

Ongoing

Date Initiated

08/19/2025

Location

Monroe, NC, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,980,000

Reason for Recall

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.

Product Description

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)

Distribution Pattern

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

Other Recalls by Greiner Bio-One North America, Inc.

• Class II: Risk 08/08/2025
  Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
• Class II: Risk 05/14/2024
  The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.

View all recalls by Greiner Bio-One North America, Inc. →