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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
Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDST AIA-PACK FER — TOSOH CORPORATIONARCHITECT — ABBOTT LABORATORIESAntiserum to Human Ferritin — KENT LABORATORIES INCTinaquant Ferritin Gen4 — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESFERR — RANDOX LABORATORIES LIMITEDIMMAGE — Beckman Coulter, Inc.N Latex Ferritin — Siemens Healthcare Diagnostics Products GmbHFerritin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics Inc.K-ASSAY® Ferritin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCADVIA Centaur® FER — Siemens Healthcare Diagnostics Inc.Ferritin ELISA — DRG International IncFERR — RANDOX LABORATORIES LIMITEDACE — ALFA WASSERMANN, INC.Dimension Vista® Flex® reagent cartridge FERR — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® FER — Siemens Healthcare Diagnostics Inc.AIA-PACK FER Sample Diluting Solution — TOSOH CORPORATIONADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics Inc.K-ASSAY® Ferritin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCAIA-PACK FER Calibration Verification Test Set — TOSOH CORPORATION
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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