FDA Device recall Z-2607-2017
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
- FDA Device
- Class II
- terminated
- Published 2017-06-28
On 2017-06-28 the FDA classified a Class II recall of Dimension Vista Digoxin (DIGXN) Flex reagent cartridge by Siemens Healthcare Diagnostics, citing 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, Dimensio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2607-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-21 |
| Published | 2017-06-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista Digoxin (DIGXN) 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.
Identifiers
| code_info | Device Listing Number # D098364 Lot # 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, 16363BA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2607-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.