Radioimmunoassay (two-site Solid Phase), Ferritin
Immunology · 21 CFR 866.5340
Recent MDR events
83 adverse event reports on file
- ELECSYS FERRITINJul 16, 2026MalfunctionRoche Diagnostics1823260-2026-02886
- ELECSYS FERRITINJun 26, 2026MalfunctionRoche Diagnostics1823260-2026-02547
- ELECSYS FERRITINJun 22, 2026MalfunctionRoche Diagnostics1823260-2026-02465
- ELECSYS FERRITINApr 17, 2026MalfunctionRoche Diagnostics1823260-2026-01474
- ELECSYS FERRITINApr 3, 2026MalfunctionRoche Diagnostics1823260-2026-01280
- ELECSYS FERRITINMar 9, 2026MalfunctionRoche Diagnostics1823260-2026-00813
- FERRITIN GEN. 2Feb 23, 2026MalfunctionRoche Diagnostics1823260-2026-00626
- ELECSYS FERRITINFeb 23, 2026MalfunctionRoche Diagnostics1823260-2026-00639
- ELECSYS FERRITINFeb 12, 2026MalfunctionRoche Diagnostics1823260-2026-00507
- ELECSYS FERRITINJan 30, 2026MalfunctionRoche Diagnostics1823260-2026-00337
Event type breakdown
Recalls
5 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Heavy Metals Test
Distribution without premarket approval/clearance.
Z-0809-2026 · View FDA record ↗ - Beckman Coulter Inc.TerminatedApr 17, 2017
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Z-1833-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedAug 15, 2014
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is use
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 (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv
Z-2238-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedDec 24, 2013
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052
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 lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
Z-0561-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Ferritin (FERR) Flex reagent cartridge
Negative Bias with Lot EA9227.
Z-2229-2019 · View FDA record ↗
Registered firms
21 firms currently registered for this product code
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Diamond Diagnostics Inc.
Budapest, HU
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Monobind, Inc.
Lake Forest, CA, US
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Mercedes Medical Llc
Lakewood Ranch, FL, US
7051395 Canada Inc Dba Hta Direct Sourcing
Champlain, NY, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Beckman Coulter, Inc.
BREA, CA, US
Beckman Coulter, Inc.
CHASKA, MN, US
Ctk Biotech, Inc.
Poway, CA, US
Scientific Supplies & Technology, Inc.
Doral, FL, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Inpeco Sa
Novazzano Ticino, CH
510(k) clearances
24 clearances for this product code
- Beckman Coulter, Inc.Mar 20, 2024
K234052 · Access Ferritin
- Beckman Coulter, Inc.Aug 19, 2005
K052082 · FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
- Boehringer Mannheim Corp.Jul 30, 1997
K964282 · TINA-QUANT FERRITIN ASSAY
- Boehringer Mannheim Corp.Jun 2, 1997
K971833 · ELECSYS FERRITIN
- Dade Chemistry Systems, Inc.Jan 24, 1997
K963498 · FERR FLEX REAGENT CARTRIDGE
- Schiapparelli Biosystems, Inc.May 16, 1995
K950393 · ACE(TM) CEDIA(R) FERRITIN ASSAY
- Bio-Rad Laboratories, Inc.Jan 13, 1993
K926221 · ACCESS FERRITIN ASSAY
- Diagnostic Products Corp.Jan 13, 1993
K925848 · IMMULITE FERRITIN