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Vidas® 3 412590

by Biomerieux SA

Ref 412590

Vidas® 3 412590 is a device classified as Class A in the EU and Class I in the US made by Biomerieux SA, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 357302BUDI000299TZ), cleared under FDA 510(k) K141133 on 9 Jul 2015 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03573026380175), active as of 12 Nov 2026. One FDA recall is linked to it.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

3 ongoing

Recall on shared 510(k) K141133; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141133

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI000299TZ Basic UDI-DI 03573026380175UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026380175 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141133 Date9 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI000299TZ registered 10 Sep 2026 Active
  • FDA 510(k) K141133 decided 9 Jul 2015 Active
  • FDA GUDID UDI-DI 03573026380175 listed 14 Sep 2016 Listed

Recalls

4 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0797-2023 FDA Class II initiated 9 Nov 2022 on shared 510(k) K141133
    • Ongoing Z-0864-2023 FDA Class II initiated 9 Nov 2022 on shared 510(k) K141133

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    • Ongoing Z-0427-2022 FDA Class II initiated 22 Sep 2021 on shared 510(k) K141133

    bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

    • Terminated Z-0928-2020 FDA Class II initiated 22 Oct 2019

    Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Cleared FDA 510(k) K141133
  2. Listed FDA GUDID 03573026380175
  3. Recall initiated FDA recalls Z-0928-2020
  4. Recall initiated FDA recalls Z-0427-2022
  5. Recall initiated FDA recalls Z-0797-2023
  6. Recall initiated FDA recalls Z-0864-2023
  7. Registered EUDAMED 357302BUDI000299TZ

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Vidas® 3
Generic name
Fluorescent immunoassay analyser IVD, laboratory
Model / reference
412590
Primary DI / UDI-DI
03573026380175
Basic UDI-DI
357302BUDI000299TZ
510(k) Number
FDA product code
JJE
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Fluorescent immunoassay analyser IVD, laboratory
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Related devices

Category: Fluorescent immunoassay analyser IVD, laboratory

Cleared under the same submission (K141133)

and 6 more cleared under K141133

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)