FDA Device recall Z-1687-2018
ADVIA Centaur¿ Cyclosporine
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of ADVIA Centaur¿ Cyclosporine 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-1687-2018 |
| 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¿ Cyclosporine
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¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 985…ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031 |
|---|
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-1687-2018%22
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