ADVIA® Chemistry UN Urea Nitrogen Reagents 10309051Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K991576); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 27, 2018Class IITerminated

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

   Z-2062-2018 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991576. One submission often covers many models, so check the product and lot details in each record.

• Z-1498-2022 · Jun 28, 2022 · Open, Classified
  Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
• Z-1658-2016 · Mar 17, 2016 · Terminated
  Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated