FDA recall Z-1679-2018

Product

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA

Reason for recall

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.

Distribution

Nationwide and Canada, Mexico, and Thailand

Key facts

Status

Terminated

Initiation date

2018-01-02

Report date

2018-05-16

Termination date

2023-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2018