FDA Device recall Z-2606-2017
Dimension Troponin 1 (TNI) 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 Troponin 1 (TNI) 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-2606-2017 |
| 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 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.
Identifiers
| code_info | Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342 " |
|---|
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-2606-2017%22
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