Recall Z-0571-2026— Greiner Bio-One North America, Inc.

Name: FDA recall Z-0571-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-19

Class II · Ongoing

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2025-08-19. It names 2 FDA 510(k) clearances: K081929, K983952. 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..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-19
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

2 on FDA's record

K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATORGreiner Bio-One North America, Inc.·cleared 2008-12-16
K983952 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner Meditech, Inc.·cleared 1998-12-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.