Z-1799-2018 Class III Terminated
FDA device recall Z-1799-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Mar 12, 2018 and is designated Class III. Reason for recall: Incorrect calibrator level listed in qualitative calibration steps The recall status is terminated (terminated Jun 2, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 12, 2018
- Termination Date
- Jun 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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 Pattern
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1799-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026