Recall Z-1668-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1668-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-02

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-01-02, terminated 2023-02-10. It names one FDA 510(k) clearance: K140842. Product: Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Terminated: 2023-02-10
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CARTSiemens Healthcare Diagnostics, Inc.·cleared 2014-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.