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Vacuette 454204

by Greiner Bio - One GmbH

Vacuette 454204 is an evacuated blood collection tube IVD (FDA Class II; FDA product code JKA, Tubes, vials, systems, serum separators, blood collection) made by Greiner Bio - One GmbH, cleared under FDA 510(k) K983952 on 28 Dec 1998 (1 earlier submission), listed under FDA premarket submission BK040066 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 29120017573344), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number29120017573344 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983952 Date28 Dec 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K983952 decided 28 Dec 1998 Active· +1 more in the status table
  • FDA premarket submission BK040066 Active· +1 more in the status table
  • FDA GUDID UDI-DI 29120017573344 listed 23 Sep 2016 Listed

Recalls

4 recalls · 2 ongoing · FDA

    • Ongoing Z-0571-2026 FDA Class II initiated 19 Aug 2025

    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.

    • Ongoing Z-2375-2024 FDA Class II initiated 14 May 2024

    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.

    • Terminated Z-0818-2020 FDA Class II initiated 25 Nov 2019

    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.

    • Terminated Z-0086-06 FDA Unclassified (pre-2012) initiated 28 Jul 2005

    Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

Timeline

7 dated events

  1. Cleared FDA 510(k) K960858
  2. Cleared FDA 510(k) K983952
  3. Recall initiated FDA recalls Z-0086-06
  4. Listed FDA GUDID 29120017573344
  5. Recall initiated FDA recalls Z-0818-2020
  6. Recall initiated FDA recalls Z-2375-2024
  7. Recall initiated FDA recalls Z-0571-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vacuette
Generic name
Evacuated blood collection tube IVD, clot activator
Model / Ref / Catalog
454204
Primary DI / UDI-DI
29120017573344
510(k) Number
FDA product code
JKA
GMDN term
Evacuated blood collection tube IVD, clot activator
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

Related devices

Category: Evacuated blood collection tube IVD, clot activator

Cleared under the same submission (BK040066)

and 8 more cleared under BK040066

Cleared under the same submission (BK050028)

and 8 more cleared under BK050028

Similar devices

Other devices filed under FDA product code JKA (Tubes, vials, systems, serum separators, blood collection).

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)