Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1673-2018)

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¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 16, 2018

Recall Number: Z-1673-2018

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:

TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA

Distribution Pattern:

Nationwide and Canada, Mexico, and Thailand

Voluntary or Mandated:

Voluntary: Firm initiated