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ADVIA Centaur EPO 10995096Recalls & reported problems

Siemens Healthcare Diagnostics Inc. · Erythropoietin (EPO) - ADVIA Centaur - RGT 100T · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K183088); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 24, 2024Open, Classified

    Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

    Z-1281-2024 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183088. One submission often covers many models, so check the product and lot details in each record.

  • Z-1280-2024 · Jan 24, 2024 · Open, Classified
    Atellica IM Erythropoietin (EPO) Assay (100 Test)

Other ASSAY, ERYTHROPOIETIN devices

All ASSAY, ERYTHROPOIETIN devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.