Ferritin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5340
Recent MDR events
23 adverse event reports on file
- TINA-QUANT FERRITIN GEN.4Oct 29, 2025MalfunctionRoche Diagnostics1823260-2025-04401
- FERR4Mar 8, 2024MalfunctionRoche Diagnostics1823260-2024-00708
- FERR4Oct 5, 2023MalfunctionRoche Diagnostics1823260-2023-03189
- FERR4Jul 12, 2023MalfunctionRoche Diagnostics1823260-2023-02226
- FERR4Jan 5, 2023MalfunctionRoche Diagnostics1823260-2023-00057
- TINA-QUANT FERRITIN GEN.4Jul 29, 2021MalfunctionRoche Diagnostics1823260-2021-02205
- TINA-QUANT FERRITIN GEN.4Apr 8, 2021MalfunctionRoche Diagnostics1823260-2021-01071
- FERR4 TINA-QUANT FERRITIN GEN.4Apr 8, 2021MalfunctionRoche Diagnostics1823260-2021-01070
- FERR4 TINA-QUANT FERRITIN GEN.4Jan 24, 2020MalfunctionRoche Diagnostics1823260-2020-00200
- ALINITY I FERRITINApr 25, 2019MalfunctionA.i.d.d Longford3005094123-2019-00134
Event type breakdown
Recalls
7 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedMay 5, 2017
Dimension Vista Ferritin (FERR) Flex reagent cartridge
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Z-2609-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedOct 24, 2014
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
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 CP system
Z-0128-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedOct 24, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
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 CP system
Z-0129-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedOct 24, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
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 CP system
Z-0130-2015 · View FDA record ↗ - Abbott Laboratories MPGTerminatedJul 4, 2006
ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories,
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 +/- 0.2).
Z-1204-06 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK Fer; Part Number: 025253
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2096-2018 · View FDA record ↗ - Abbott Ireland Diagnostics DivisionTerminatedUnknown
Alinity i Ferritin Reagent Kit, List Number 07P6530
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 Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Z-2208-2019 · View FDA record ↗
Registered firms
58 firms currently registered for this product code
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Abbott Ireland Diagnostics Division
Longford, IE
Kamiya Biomedical Company Llc
Tukwila, WA, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Lumiquick Diagnostics, Inc.
SANTA CLARA, CA, US
Horiba Abx Sas
MONTPELLIER Herault, FR
Beckman Coulter Biomedical Gmbh
Munchen Bavaria, DE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Abbott Laboratories
Lake Forest, IL, US
Acro Biotech Inc.
Montclair, CA, US
Diasorin Deutschland Gmbh
Dietzenbach Hesse, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Tosoh Corp.
Chuo-ku Tokyo, JP
Alfa Wassermann
West Caldwell, NJ, US
Tosoh Bioscience, Inc.
Grove City, OH, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Tosoh Aia, Inc.
TOYAMA, JP
510(k) clearances
87 clearances for this product code
- DiaSorin, Inc.Sep 14, 2021
K193650 · LIAISON Ferritin
- HORIBA ABX SASMar 6, 2020
K191562 · Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- Siemens Healthcare Diagnostics, Inc.Aug 31, 2017
K171642 · Atellica IM Ferritin Assay
- Diazyme LaboratoriesJun 24, 2014
K133083 · DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- Kamiya Biomedical CompanyMay 24, 2012
K121232 · K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
- Siemens Healthcare Diagnostics, Inc.Aug 17, 2011
K110736 · ADVIA CHEMISTRY FERRITIN (FRT) METHOD
- Roche DiagnosticsJun 22, 2010
K100538 · TINA-QUANT FERRITIN GEN. 4
- Beckman Coulter, Inc.Dec 11, 2009
K092505 · BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203