Greiner Bio-One North America, Inc.: Brand Name: Vacuette Product Name: 8 ml CAT Serum Se

Greiner Bio-One North America, Inc.: Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VAC

Medical DevicesSource: FDA (device) · Date: 2025-11-26

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: 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 / hazard: 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
Status: Ongoing
Distribution / sold at: 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
Recall initiated: 2025-08-19
Code info: Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
Product quantity: 1,980,000
Voluntary mandated: Voluntary: Firm initiated
City: Monroe
State: NC
Country: United States
Event id: 97499