Recall Z-2606-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2606-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-21

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-03-21, terminated 2018-08-03. It names one FDA 510(k) clearance: K081643. Product: Dimension Troponin 1 (TNI) Flex reagent cartridge. Reason: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-21
Terminated: 2018-08-03
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692Siemens Healthcare Diagnostics·cleared 2008-07-03

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 Troponin 1 (TNI) Flex reagent cartridge

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

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