FDA recall Z-1668-2018

Product

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

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.

Distribution

Nationwide and Canada, Mexico, and Thailand

Key facts

Status

Terminated

Initiation date

2018-01-02

Report date

2018-05-16

Termination date

2023-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2018