Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (La) Flex Reagent Cartri

• • Terminated Z-1540-2018 FDA Class II ·initiated 30 Jan 2018 ·on shared 510(k) K061792

  May produce erroneously low results from specific well sets.

• • Terminated Z-0039-2017 FDA Class II ·initiated 3 Aug 2016 ·on shared 510(k) K061792

  Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

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

510(k) Number

K061792 ↗

FDA Product Code

DIC

Device Class

Class II

Regulation

21 CFR Part 862.3040

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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