United StatesThe affected product is Greiner Bio‑One’s Vacuette 8 ml CAT Serum Separator Clot Activator blood collection tube (16 x 100 mm, 8 ml), catalog/item #455071P, Lot #B250437N, UDI‑DI 29120017573061. It was recalled because some tubes were manufactured without the gel separator, which could yield erroneous assay results, require patient recollection or repeat testing, and may delay diagnosis or clinical decision‑making, or in rare cases produce incorrect results from less stable parameters.
What's being recalled
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)
Recalling firm: Greiner Bio-One North America, Inc., Monroe, NC, United States.
How to identify it
Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)