Drug recall
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P…
FDA recall event 97499 · Class II · Greiner Bio-One North America, Inc.
Key facts
| Event ID | 97499 |
|---|---|
| Recall numbers | Z-0571-2026 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 19, 2025 |
| Report date | Nov 26, 2025 |
| City | Monroe |
| State | NC |
| Country | United States |
| FEI number | 3001451379 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: