Minividas Instrument

• 2 recalls, same reason

  • Terminated Z-2429-2018 FDA Class II ·initiated 4 Jan 2018
  • Terminated Z-2428-2018 FDA Class II ·initiated 4 Jan 2018

  Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a decrease of pipetted volume.

510(k) Number

K923579 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vitek Immun Assay Sys(Vidas) Thyroi Stim Hor Assay

  Class II

  FDA 510(k) K921816 Active Cleared 18 Jun 1992

• Hemolab

  Class II

  FDA 510(k) K931992 Active Cleared 22 Dec 1994

• Vidas Creatine Kinase Mb Assay 30-421

  Class II

  FDA 510(k) K962549 Active Cleared 30 Aug 1996

• Vidas Rotavirus (Rtv) Assay

  Class I

  FDA 510(k) K972895 Active Cleared 3 Oct 1997

• Hemolab Silimat Reagent

  Class I

  FDA 510(k) K920001 Active Cleared 25 Sep 1992

• Vidas T Uptake

  Class II

  FDA 510(k) K935816 Active Cleared 22 Mar 1994

See all devices from Biomerieux Vitek, Inc. →