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Access Ferritin Calibrators
Beckman Coulter, Inc. · Model 33025 · UDI-DI 15099590575045
JMG
Prescription
10
510(k) clearances
85
Adverse events (1 deaths)
5
Recalls
16
Facilities
Description
The Access Ferritin Calibrators are intended to calibrate the Access Ferritin assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
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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Get your free API keyRead the docsData 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.