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 VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

Recall number

Z-0571-2026

Recalling firm

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)

Status

Open, Classified

Initiated

2025-08-19

Posted

2025-11-19

Terminated

not on file

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.

Root cause

Labeling Change Control

Action

On 08/22/2025, the firm sent via email an "Urgent Medical Device Correction" letter to customer informing them that some Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator which may affect the stability of the sample. Customers are instructed to: " Stop use immediately: Discontinue use of the affected product (concerned Item/Lot) and isolate it within your facility. " Notify staff and customers: Inform all relevant employees and notify all customers to whom you distributed the affected products. " Assess risk: Evaluate potential risks or consequences in accordance with your internal procedures and take appropriate action. " Confirm product disposition: Complete the attached Product Disposition Site Confirmation Form and return it via fax to 877-217-7927 or email to recalls.us@gbo.com. Confirmation is required that all affected products have been discarded/destroyed. Replacement products will be provided upon receipt of your completed form. For questions, call Greiner Bio-One Technical Service at 800-515-8112.

Quantity

1,980,000

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

Lot, serial or model codes

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

510(k) numbers

["K081929","K983952"]

PMA numbers

not on file

Product code

JKA

Firm FEI

3001451379

Firm city

Monroe

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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