FDA Device recall Z-1669-2018
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge by Siemens Healthcare Diagnostics, citing the concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1669-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-02 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Reason
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
Identifiers
| code_info | FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8…FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254 |
|---|
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-1669-2018%22
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