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HemosIL ReadiPlasTin

by Instrumentation Laboratory Company

Ref 0020301400

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213426↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number842695063288795 Basic UDI-DI 08426950632887UDI-DIDate22 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK213426 Date16 Aug 2022IssuedStatusActive
United StatesGUDID listing GUDID Number08426950632887 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

4 recalls · 2 ongoing · FDA

    • Ongoing Z-1052-2022 FDA Class II initiated 8 Apr 2022

    Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

    • Ongoing Z-0276-2022 FDA Class II initiated 13 Oct 2021

    The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

    • Terminated Z-0077-2019 FDA Class II initiated 1 Aug 2018

    There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

    • Terminated Z-0895-2018 FDA Class II initiated 2 Aug 2017

    Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
HemosIL ReadiPlasTin EUDAMED
HemosIL ReadiPlasTin (20 mL) GUDID
Generic Name
Prothrombin time (PT) IVD, kit, clotting
Model / Ref / Catalog
0020301400 EUDAMED
00020301400 GUDID
Primary DI / UDI-DI
08426950632887
Basic UDI-DI
842695063288795
Direct Marketing DI
08426950632887
510(k) Number
FDA Product Code
GJS
EMDN Code
W0103020101 Prothrombin time ( quick test )
GMDN Term
Prothrombin time (PT) IVD, kit, clotting
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
864.7750
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0020301400
GUDID
00020301400
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

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: 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