Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL… — Class III medical device recall Z-1800-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-16, distributed in FL, KS, KY, MA, ME, NH, PA, TX…. Incorrect calibrator level listed in qualitative calibration steps
| Recall number | Z-1800-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2018-03-12 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-06-02 |
| Distributed | FL, KS, KY, MA, ME, NH, PA, TX, UT |
| Model numbers | 10470440, 9R039UL |
Product
Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Reason for recall
Incorrect calibrator level listed in qualitative calibration steps
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-1800-2018. 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.