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)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | August 19, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Country / region | United States NC |
Hazard
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.
Affected products
- Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collecti
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