Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1668-2018)

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¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1668-2018

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:

TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated