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Sp Cal (Liq) IT2691

by Randox Laboratories, Ltd.

Sp Cal (Liq) IT2691 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K061056 on 20 Jul 2006 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273204032), active as of 22 Oct 2026. 3 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

510(k) K061056

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273204032 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK061056 Date20 Jul 2006IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061056 decided 20 Jul 2006 Active
  • FDA GUDID UDI-DI 05055273204032 listed 16 Sep 2016 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-1328-2024 FDA Class II initiated 1 Mar 2024

    The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

    • Ongoing Z-2448-2023 FDA Class II initiated 19 Jul 2023

    As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

    • Terminated Z-0283-2020 FDA Class II initiated 9 Aug 2019

    The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

Timeline

5 dated events

  1. Cleared FDA 510(k) K061056
  2. Listed FDA GUDID 05055273204032
  3. Recall initiated FDA recalls Z-0283-2020
  4. Recall initiated FDA recalls Z-2448-2023
  5. Recall initiated FDA recalls Z-1328-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sp Cal (Liq)
Generic name
Multiple clinical chemistry protein IVD, calibrator
Model / Ref / Catalog
IT2691
Primary DI / UDI-DI
05055273204032
510(k) Number
FDA product code
JIX
GMDN term
Multiple clinical chemistry protein IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple clinical chemistry protein IVD, calibrator

Similar devices

Other devices filed under FDA product code JIX (Calibrator, Multi-Analyte Mixture).

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

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