FDA Device recall Z-1668-2018
Dimension¿ Thyroid Stimulating Hormone (TSHL) 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¿ Thyroid Stimulating Hormone (TSHL) 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-1668-2018 |
| 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¿ Thyroid Stimulating Hormone (TSHL) 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 | TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346…TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261 |
|---|
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-1668-2018%22
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