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Ferritin, Antigen, Antiserum, Control
FDA product code DBF · Class 2 · Immunology
45
Registered devices
23
Adverse events
7
Recalls
87
510(k) clearances
Devices with this code
Tina-quant Ferritin Gen.4 — Roche Diagnostics GmbHK-ASSAY® Ferritin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCAntiserum to Human Ferritin — KENT LABORATORIES INCYumizen C1200 Ferritin — HORIBA ABX SASTinaquant Ferritin Gen4 — Roche Diagnostics GmbHN Latex Ferritin — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESACE — ALFA WASSERMANN, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSTinaquant Ferritin Gen4 — Roche Diagnostics GmbHSpectro Ferritin MT — Ramco Laboratories, Inc.Ferritin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Tinaquant Ferritin Gen4 — Roche Diagnostics GmbHARCHITECT — ABBOTT IRELANDIMMAGE — Beckman Coulter, Inc.AIA-PACK FER Sample Diluting Solution — TOSOH CORPORATIONADVIA Centaur® FER — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDAtellica IM Fer — Siemens Healthcare Diagnostics Inc.Ferritin ELISA — DRG International IncK-ASSAY® Ferritin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCTinaquant Ferritin Gen4 — Roche Diagnostics GmbHADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Append |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2017-03-21 | Siemens Healthcare Diagnostics, Inc. | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dime |
| 2012-10-09 | Siemens Healthcare Diagnostics, Inc | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur C |
| 2012-10-09 | Siemens Healthcare Diagnostics, Inc | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur C |
| 2012-10-09 | Siemens Healthcare Diagnostics, Inc | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur C |
| 2006-06-06 | Abbott Laboratories MPG | Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0 |
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