# FDA recall Z-2607-2017

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-03-21.

## Product

Dimension Vista Digoxin (DIGXN) 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2607-2017
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-03-21
- **Report date:** 2017-06-28
- **Termination date:** 2018-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2607-2017

## Citation

> AI Analytics. FDA recall Z-2607-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2607-2017. Source: US FDA. Licensed CC0.

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