Skip to content

Vacuette 454337H

by Greiner Bio - One GmbH

Ref 454337HModel VACUETTE® Coagulation sodium citrate

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-19120017578922 Basic UDI-DI 19120017578922UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120017578922 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-0408-2026 FDA Class II initiated 8 Aug 2025

    Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

    • Terminated Z-2507-2021 FDA Class II initiated 20 Aug 2021

    Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

    • Terminated Z-1534-2021 FDA Class II initiated 29 Mar 2021

    VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

    • Terminated Z-1714-2020 FDA Class II initiated 12 Mar 2020

    Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

    • Terminated Z-2154-2012 FDA Class II initiated 2 Jul 2012

    Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

    • Terminated Z-1498-06 FDA Unclassified (pre-2012) initiated 2 Aug 2006

    Coagulation tubes found with no additive.

    • Terminated Z-1331-04 FDA Unclassified (pre-2012) initiated 27 Jul 2004

    Coagulation tubes may not have received the proper fill of citrate solution.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring EUDAMED
Vacuette GUDID
Generic Name
Evacuated blood collection tube IVD, anticoagulant
Device Name
VACUETTE® Coagulation sodium citrate
Model / Ref / Catalog
454337H, VACUETTE® Coagulation sodium citrate
Primary DI / UDI-DI
19120017578922 EUDAMED
29120017578929 GUDID
Basic UDI-DI
B-19120017578922
510(k) Number
FDA Product Code
GIM
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
GMDN Term
Evacuated blood collection tube IVD, anticoagulant
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1675
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
19120017578922
GUDID
29120017578929
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Cleared under the same submission (K971221)

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Sterile
  • Single Use
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No