Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Recalled Product
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Hazard / Issue
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.
Issued by
FDA
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