Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2606-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Dimension Troponin 1 (TNI) Flex reagent cartridge

Product Classification:

Class II

Date Initiated: March 21, 2017

Date Posted: June 28, 2017

Recall Number: Z-2606-2017

Event ID: 76915

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.

Status: Terminated

Product Quantity: 70,428 units

Code Information:

Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342 "

Distribution Pattern:

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

Voluntary or Mandated:

Voluntary: Firm initiated