FDA recall Z-2062-2018

Product

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

Nationwide and worldwide

Key facts

Status

Terminated

Initiation date

2018-03-27

Report date

2018-06-13

Termination date

2021-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2018