Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308

Recall date

July 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0829-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

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Why it was recalled

Homocysteine Assay May Cause Elevated Results in the Folate Assay

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308