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Access Ferritin

Beckman Coulter, Inc. · Model C22490 · UDI-DI 15099590772840

JMG Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2019-07-15	Siemens Healthcare Diagnostics, Inc.	Negative Bias with Lot EA9227.
2017-03-10	Beckman Coulter Inc.	Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
2014-07-15	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (
2013-05-06	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lo

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.