Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1671-2018)

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:

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1671-2018

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:

CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 17045BC 17054BD 17074BC 17093BD 17121BA 17145BE 17180BB 17193BD 17201BB 17223BA 17264BC

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated