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Cal 3 CAL2351

by Randox Laboratories, Ltd.

Ref CAL2351

Cal 3 CAL2351 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code JIX, Calibrator, Multi-Analyte Mixture; EMDN category calibrators multicomponent (cc)) made by Randox Laboratories, Ltd., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-05055273200966), cleared under FDA 510(k) K053153 on 13 Jan 2006 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273200966), active as of 7 Nov 2026. 6 FDA recalls are linked to it.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

4 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K053153

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055273200966 Basic UDI-DI 05055273200966UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273200966 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK053153 Date13 Jan 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273200966 registered 28 Oct 2026 Active
  • FDA 510(k) K053153 decided 13 Jan 2006 Active
  • FDA GUDID UDI-DI 05055273200966 listed 16 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

6 recalls · 4 ongoing · FDA

    • Ongoing Z-1759-2024 FDA Class II initiated 5 Mar 2024

    Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

    • Ongoing Z-0753-2024 FDA Class II initiated 20 Nov 2023

    Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

    • Ongoing Z-0752-2024 FDA Class II initiated 20 Nov 2023

    CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

    • Ongoing Z-0751-2024 FDA Class II initiated 13 Nov 2023

    There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

    • Terminated Z-1563-2021 FDA Class II initiated 29 Mar 2021

    Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

    • Terminated Z-2490-2019 FDA Class III initiated 12 Jul 2019

    Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

Timeline

9 dated events

  1. Cleared FDA 510(k) K053153
  2. Listed FDA GUDID 05055273200966
  3. Recall initiated FDA recalls Z-2490-2019
  4. Recall initiated FDA recalls Z-1563-2021
  5. Recall initiated FDA recalls Z-0751-2024
  6. Recall initiated FDA recalls Z-0753-2024
  7. Recall initiated FDA recalls Z-0752-2024
  8. Recall initiated FDA recalls Z-1759-2024
  9. Registered EUDAMED B-05055273200966

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Calibration Serum Level 3 (Cal 3) EUDAMED
Cal 3 GUDID
Generic name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
CAL2351
Primary DI / UDI-DI
05055273200966
Basic UDI-DI
B-05055273200966
510(k) Number
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, calibrator

Cleared under the same submission (K053153)

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)