medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

Recalled Product

IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

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

Distribution: Nationwide (United States)
Lot/Code Info: OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213
View official government recall

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