FDA Device recall Z-0818-2020
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a…
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a… by Greiner Bio One North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0818-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-25 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Greiner Bio One North America |
| Distribution | US |
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.
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.
Identifiers
| code_info | DI: 29120049204476, Lot number B190338E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0818-2020%22
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