Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1677-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1677-2018

Event ID: 79505

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.

Status: Terminated

Product Quantity: N/A

Code Information:

BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) Lot codes: 0312 0313

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated