FDA Device recall Z-1799-2018
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
- FDA Device
- Class III
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class III recall of Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 by Siemens Healthcare Diagnostics, citing incorrect calibrator level listed in qualitative calibration steps.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1799-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-12 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | FL, KS, KY, MA, ME, NH, PA, TX, UT |
Product
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Reason
Incorrect calibrator level listed in qualitative calibration steps
Identifiers
| code_info | All lots |
|---|
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-1799-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.