Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge

Recall date

January 2, 2018

Source

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

Recall number

Z-1670-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Nationwide and Canada, Mexico, and Thailand

Why it was recalled

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

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

What was recalled

Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge