Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1690-2018)

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:

ADVIA Centaur¿ HBc IgM

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1690-2018

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: 6

Code Information:

ADVIA Centaur¿ HBc IgM; test, hepatitis b (b core, be antigen, be antibody, b core igm); SMN 10308978 Lot codes: ADVIA Centaur aHBcM Lot # 02437164 14331164 20876164 29394164 81764164 93146164 26976167 39604167 44125167 56754167 67635167 77328167 01396170 07110170 21484170 67103170 86117170 92364170 31751171 33726171 41538171 ***Added 9/11/20*** 10308978 ***Added 11/2/20*** 62572190 ***Added 3/11/21*** 39927194

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated