Skip to content

HemosIL LMW Heparin Controls

by Instrumentation Laboratory Company

Ref 0020300200

Active European Union. Also listed in GUDID (US).

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number84269504724908Q Basic UDI-DI 08426950472490UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950472490 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-2323-2025 FDA Class II initiated 3 Feb 2025

    Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Heparin anti-Xa IVD, control
Model / Ref / Catalog
0020300200 EUDAMED
00020300200 GUDID
Primary DI / UDI-DI
08426950472490
Basic UDI-DI
84269504724908Q
Direct Marketing DI
08426950472490
510(k) Number
FDA Product Code
KFF
EMDN Code
W0103020702 Control plasma for haemostasis
GMDN Term
Heparin anti-Xa IVD, control
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
864.7525
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0020300200
GUDID
00020300200
Device ClassEUDAMED
Class C
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000035586
Authorised representative
Instrumentation Laboratory SpA IT-AR-000008169

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

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