FDA Device recall Z-1688-2018
ADVIA Centaur¿ DHEA-SO4
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of ADVIA Centaur¿ DHEA-SO4 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-1688-2018 |
| 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
ADVIA Centaur¿ DHEA-SO4
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 | ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHE…ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057 |
|---|
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-1688-2018%22
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