Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692

510(k) K081643

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK081643	Date3 Jul 2008Cleared	StatusActive

4 recalls · FDA

- Terminated Z-2436-2018 FDA Class II initiated 21 Mar 2018
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
- Terminated Z-2606-2017 FDA Class II initiated 21 Mar 2017
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-0069-2012 FDA Unclassified (pre-2012) initiated 31 Aug 2011 on shared 510(k) K081643
Firm has confirmed customer complaints for low recovery of QC and patient samples.
- Terminated Z-0460-2011 FDA Unclassified (pre-2012) initiated 12 Apr 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.

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)