Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent

510(k) K140859

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK140859	Date26 Nov 2014Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1673-2018 FDA Class II initiated 2 Jan 2018 on shared 510(k) K140859
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.
- Terminated Z-2611-2017 FDA Class II initiated 21 Mar 2017 on shared 510(k) K140859
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
- Terminated Z-1708-2015 FDA Class II initiated 20 Apr 2015 on shared 510(k) K140859
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)