Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Cata…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0571-2026
• FDA 510(k) clearance · K081929The device's official FDA premarket clearance record
• FDA 510(k) clearance · K983952The device's official FDA premarket clearance record
• FDA device classification · JKAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1675The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Greiner Bio-One North America, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.