medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

Recalled Product

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

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: Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6) Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514
View official government recall

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