Radioimmunoassay, Free Thyroxine
Siemens Healthcare Diagnostics Inc.'s record for this product code
Recent MDR events
50 adverse event reports on file
- DIMENSION VISTA®Dec 18, 2019Malfunction2517506-2019-00479
- DIMENSION VISTA®Jun 28, 2018Malfunction2517506-2018-00396
- DIMENSION VISTA®Jun 28, 2018Malfunction2517506-2018-00397
- DIMENSION VISTA®Jul 11, 2017Malfunction2517506-2017-00573
- DIMENSION VISTA®Jul 10, 2017Malfunction2517506-2017-00562
- DIMENSION VISTA®Jul 7, 2017Malfunction2517506-2017-00520
- DIMENSION VISTA®Jul 7, 2017Malfunction2517506-2017-00551
- DIMENSION VISTA®Jul 7, 2017Malfunction2517506-2017-00550
- DIMENSION VISTA®Jul 7, 2017Malfunction2517506-2017-00553
- DIMENSION VISTA®Jun 29, 2017Malfunction2517506-2017-00559
Recalls
2 recall events for this product code
- TerminatedMay 4, 2018
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
View FDA record ↗ - TerminatedNov 24, 2010
Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.
View FDA record ↗
510(k) clearances
4 clearances for this product code
- K140859Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- K140842Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- K132249Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
- K083373Feb 2, 2009
IMMULITE 2000 FREE T4