FDA recall Z-1799-2018
Siemens Healthcare Diagnostics, Inc. · Class III · device
Product
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Reason for recall
Incorrect calibrator level listed in qualitative calibration steps
Distribution
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Key facts
- Status
- Terminated
- Initiation date
- 2018-03-12
- Report date
- 2018-05-16
- Termination date
- 2020-06-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tarrytown, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1799-2018