Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator

• • Terminated Z-1869-2012 FDA Class II ·initiated 8 May 2012

  Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System.

510(k) Number

K071224 ↗

FDA Product Code

CDD

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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