medical Class II Updated 2018-06-13

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urea Nitrogen Reagent (material number 10309

Recalled Product

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

Hazard / Issue

Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
View official government recall

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