Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number...
FDA Device Recall #Z-0571-2026 — Class II — August 19, 2025
Recall Summary
| Recall Number | Z-0571-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 19, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Greiner Bio-One North America, Inc. |
| Location | Monroe, NC |
| Product Type | Devices |
| Quantity | 1,980,000 |
Product Description
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 for Recall
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.
Distribution Pattern
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 / Code Information
Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
Other Recalls from Greiner Bio-One North America, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0408-2026 | Class II | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation s... | Aug 8, 2025 |
| Z-2375-2024 | Class II | VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Ac... | May 14, 2024 |
| Z-0733-2024 | Class II | VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium... | Dec 12, 2023 |
| Z-1583-2023 | Class II | greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, ... | Mar 31, 2023 |
| Z-0502-2022 | Class II | greiner bio-one VACUETTE TUBE, 5 ml LH Lithium ... | Dec 9, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.