Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1669-2018)

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¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1669-2018

Event ID: 79505

Reason for Recall:

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Status: Terminated

Product Quantity: N/A

Code Information:

FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated