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Recall Observatory FDA recall evidence

Device product

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

Z-2062-2018

March 27, 2018

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 79932
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2062-2018

Official wording

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

Code information: Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513

Distribution pattern: Nationwide and worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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