Class II — Greiner Bio-One North America, Inc.
| Recalling firm | GREINER BIO-ONE NA |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 1,002,000 tubes |
| Distribution | Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA |
| Initiated | 2019-11-25 |
| Classified | 2020-01-17 |
| Terminated | 2020-10-05 |
| Recall number | Z-0818-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greiner Bio-One North America, Inc. (Z-0818-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84536/
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