# Vacuette 454067P

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vacuette-454067p>
- Manufacturer: [Greiner Bio - One GmbH](https://devicerts.com/manufacturers/greiner-bio-one-gmbh) (Germany)
- Device class: Class II (US FDA)
- FDA product code: JKA
- GMDN: Evacuated blood collection tube IVD, clot activator/separator (41128)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 29120049204476 · listed 2016-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K983952 · decision 1998-12-28 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K960858 · decision 1996-08-30 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · BK040066 · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · BK050028 · status: Active · from GUDID

## Recalls

- Z-0571-2026 · Class II · ongoing · initiated 2025-08-19: 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.
- Z-2375-2024 · Class II · ongoing · initiated 2024-05-14: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
- Z-0818-2020 · Class II · terminated · initiated 2019-11-25: 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.
- Z-0086-06 ·  · terminated · initiated 2005-07-28: Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

## Identity

- Trade name: Vacuette [FDA GUDID (AccessGUDID)]
- Generic name: Evacuated blood collection tube IVD, clot activator/separator [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 454067P [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 29120049204476 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K960858 [FDA GUDID (AccessGUDID)]; K983952 [FDA GUDID (AccessGUDID)]
- FDA product code: JKA [FDA GUDID (AccessGUDID)]
- GMDN term: Evacuated blood collection tube IVD, clot activator/separator (41128) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1675 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Vacuette 454067P, Greiner Bio - One GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/vacuette-454067p (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/vacuette-454067p.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vacuette-454067p
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.