VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, H...
FDA Device Recall #Z-0818-2020 — Class II — November 25, 2019
Recall Summary
| Recall Number | Z-0818-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Greiner Bio-One North America, Inc. |
| Location | Monroe, NC |
| Product Type | Devices |
| Quantity | 1,002,000 tubes |
Product Description
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
Reason for Recall
The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
Distribution Pattern
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Lot / Code Information
DI: 29120049204476, Lot number B190338E
Other Recalls from Greiner Bio-One North America, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0571-2026 | Class II | Brand Name: Vacuette Product Name: 8 ml CAT Se... | Aug 19, 2025 |
| 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 |
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.