Z-2062-2018 Class II Terminated
FDA device recall Z-2062-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Mar 27, 2018 and is designated Class II. Reason for recall: Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. The recall status is terminated (terminated Feb 3, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- Mar 27, 2018
- Termination Date
- Feb 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Distribution Pattern
Nationwide and worldwide
Code Information
Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2062-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026