Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)

• • Terminated Z-2609-2017 FDA Class II ·initiated 21 Mar 2017 ·on shared 510(k) K070552

  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.

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

510(k) Number

K070552 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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