Syva Emit Methotrexate Assay — Class II medical device recall Z-1618-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-05-18, distributed in CA, DC, FL, GA, MI, MT, NC, NJ…. Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista
| Recall number | Z-1618-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-03-08 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-08-07 |
| Distributed | CA, DC, FL, GA, MI, MT, NC, NJ, NY, PA, TX, VA |
| Countries outside the US | AU, BE, CH, CZ, ES, FI, IT, JP, KR, SA, SI, SK |
| Quantity | 18,364 units |
| Reason classes | specification failure |
Product
Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
Reason for recall
Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.
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-1618-2016. 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.