Z-2062-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- March 27, 2018
- Termination Date
- February 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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