Dimension Vista¿ Thyroid Stimulating Hormone — Class II medical device recall Z-1673-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-16, distributed nationwide. The concentrations for biotin listed in the non-interfering substances section of the instructions for use for
| Recall number | Z-1673-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2018-01-02 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2023-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, TH |
| Lot numbers | 16277BD, 16322BB, 17005BB, 17023AC, 17069AA, 17093BB, 17122AA, 17150AA, 17193BA, 17215AC, 17268AA |
Product
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1673-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.