AMMONIA (NH3) AM1054Recalls & 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.

1 other recall cover devices cleared under the same FDA submission (K030873); 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. Jul 30, 2020Class IITerminated

   Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.

   Z-2966-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030873. One submission often covers many models, so check the product and lot details in each record.

• Z-2965-2020 · Jul 30, 2020 · Terminated
  AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma