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Vidas 3 1.3

by Biomerieux SA

Vidas 3 1.3 is a Class I device made by Biomerieux SA, cleared under FDA 510(k) K141133 on 9 Jul 2015 and listed in FDA GUDID since 19 Oct 2018 (UDI-DI 03573026608866), active as of 12 Nov 2026. One FDA recall is 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

3 ongoing

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

Documents

510(k) K141133

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03573026608866 UDI-DI Date19 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141133 Date9 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141133 decided 9 Jul 2015 Active
  • FDA GUDID UDI-DI 03573026608866 listed 19 Oct 2018 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

6 dated events

  1. Cleared FDA 510(k) K141133
  2. Listed FDA GUDID 03573026608866
  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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vidas 3
Generic name
Fluorescent immunoassay analyser IVD, laboratory
Model / reference
1.3
Primary DI / UDI-DI
03573026608866
510(k) Number
FDA product code
JJE
GMDN term
Fluorescent immunoassay analyser IVD, laboratory
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fluorescent immunoassay analyser IVD, laboratory

Cleared under the same submission (K141133)

and 6 more cleared under K141133

Similar devices

Other devices filed under FDA product code JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE).

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Prescription use
Other properties (14, all answered No)