Skip to content

Atellica IM HCY Calibrator 10995498Recalls & reported problems

Siemens Healthcare Diagnostics Inc. · Homocysteine Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL · 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.

2 other recalls cover devices cleared under the same FDA submission (K013406); 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. Apr 15, 2025Open, Classified

    Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

    Z-1821-2025 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013406. One submission often covers many models, so check the product and lot details in each record.

  • Z-1822-2025 · Apr 15, 2025 · Open, Classified
    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
  • Z-1960-2014 · Jun 25, 2013 · Terminated
    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centa

Other Calibrator, primary devices

All Calibrator, primary devices →

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