ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents 10341115Recalls & 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 (K063845, K170065); 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. Feb 13, 2020Class IITerminated

   Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

   Z-1539-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063845, K170065. One submission often covers many models, so check the product and lot details in each record.

• Z-2471-2023 · Jul 10, 2023 · Open, Classified
  Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test