ADVIA Chemistry Urea Nitrogen Reagent — Class II medical device recall Z-2062-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-06-13, distributed nationwide. Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be gener
| Recall number | Z-2062-2018 |
|---|---|
| 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 | 2018-03-27 |
| Classified | 2018-06-04 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2021-02-03 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00630414517513 |
Product
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Reason for recall
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
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-2062-2018. 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.