Complement C4, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5240
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Roche Diagnostics Operations, Inc.TerminatedUnknown
Tina-quant Complement C4 ver.2, Catalog 05991994190
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Z-0103-2021 · View FDA record ↗ - Abbott Laboratories, IncTerminatedUnknown
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Z-1992-2019 · View FDA record ↗
Registered firms
45 firms currently registered for this product code
The Binding Site Group Ltd.
BIRMINGHAM, GB
Ortho Clinical Diagnostics
Singapore South West, SG
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Kamiya Biomedical Company Llc
Tukwila, WA, US
Diamond Diagnostics Inc.
Budapest, HU
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Millstone Medical Outsourcing Llc
Olive Branch, MS, US
Abbott Laboratories
Irving, TX, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Abbott Gmbh
Wiesbaden Hesse, DE
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Fisher Diagnostics
MIDDLETOWN, VA, US
Abbott Laboratories
Lake Forest, IL, US
The Binding Site
Kings Norton Birmingham, GB
Beckman Coulter, Inc.
BREA, CA, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
510(k) clearances
34 clearances for this product code
- The Binding SiteSep 3, 2010
K100455 · SPAPLUS ANALYZER
- Roche Diagnostics Corp.Nov 29, 2001
K012359 · TINA-QUANT COMPLEMENT C4 TEST SYSTEM
- Wako Chemicals USA, Inc.Jun 25, 2001
K010325 · WAKO AUTOKIT C4
- Randox Laboratories, Ltd.Mar 27, 2000
K000468 · RANDOX COMPLEMENT C4
- Dade Behring, Inc.Mar 1, 2000
K994293 · DIMENSION C4 FLEX REAGENT CARTRIDGE
- The Binding Site, Ltd.Dec 20, 1999
K981785 · C4 MININEPH ANTISERUM
- Kamiya Biomedical Co.Nov 29, 1999
K993481 · K-ASSAY C4
- Abbott LaboratoriesNov 4, 1998
K983356 · C4