Vacuette Serum Separator (Greiner Bio-One) – Missing Gel Separator (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Greiner Bio-One North America, Inc.
Lot Codes / Batch Numbers
Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
Products Sold
Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
Greiner Bio-One North America, Inc. is recalling Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455 due to Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, ME, MD, MA, MI, MS, MO, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WY
Page updated: Jan 10, 2026