VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator — Class II medical device recall Z-3027-2020
Terminated recall by Greiner Bio-One North America, Inc., reported 2020-10-07, distributed nationwide. Blood collection tubes experienced an issue with separation and clotting
| Recall number | Z-3027-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2020-08-28 |
| Classified | 2020-09-29 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,008,000 units |
| Lot numbers | B2003399 |
| Model numbers | 456018P |
Product
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
Reason for recall
Blood collection tubes experienced an issue with separation and clotting
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3027-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.