Radioimmunoassay, C-peptides Of Proinsulin
Clinical Chemistry · 21 CFR 862.1135
Recent MDR events
19 adverse event reports on file
- ELECSYS C-PEPTIDESep 5, 2025MalfunctionRoche Diagnostics1823260-2025-02772
- ELECSYS C-PEPTIDEAug 25, 2025MalfunctionRoche Diagnostics1823260-2025-02604
- ELECSYS C-PEPTIDEJul 30, 2025MalfunctionRoche Diagnostics1823260-2025-02351
- ELECSYS C-PEPTIDEDec 12, 2022MalfunctionRoche Diagnostics1823260-2022-03963
- ELECSYS C-PEPTIDEAug 19, 2021MalfunctionRoche Diagnostics1823260-2021-02416
- ELECSYS C-PEPTIDESep 10, 2020MalfunctionRoche Diagnostics1823260-2020-02232
- ARCHITECT C-PEPTIDE REAGENTOct 26, 2011MalfunctionAbbott Laboratories1415939-2011-00672
- ARCHITECT C-PEPTIDE REAGENTOct 20, 2011MalfunctionAbbott Laboratories1415939-2011-00654
- ARCHITECT C-PEPTIDE REAGENTAug 6, 2011MalfunctionAbbott Laboratories1415939-2011-00522
- ARCHITECT C-PEPTIDE REAGENTAug 6, 2011MalfunctionAbbott Laboratories1415939-2011-00523
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- DRG International, Inc.TerminatedUnknown
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine.
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Z-0896-2022 · View FDA record ↗ - Abbott LaboratoriesTerminatedUnknown
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mel
Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
Z-1895-2020 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK C-Peptide; Part Number: 025284
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2074-2018 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK C-Peptide II; Part Number: 025283
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2075-2018 · View FDA record ↗ - Abbott LaboratoriesTerminatedUnknown
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and
C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.
Z-3031-2011 · View FDA record ↗
Registered firms
39 firms currently registered for this product code
Invitron
Monmouth Monmouthshire, GB
American Laboratory Products Company
Salem, NH, US
Getein Biotech, Inc.
Nanjing Jiangsu, CN
Tosoh Bioscience, Inc.
Grove City, OH, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Diamond Diagnostics Inc.
Budapest, HU
Diasorin Deutschland Gmbh
Dietzenbach Hesse, DE
Shenzhen Yhlo Biotech Co., Ltd.
Shenzhen Guangdong, CN
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Drg International, Inc.
Springfield, NJ, US
Immunocentrix Corporation
Canoga Park, CA, US
Canon Medical Diagnostics Corporation Fuji Plant.
SUNTO-GUN Shizuoka, JP
Diasource Immunoassays, Sa
Louvain-La-Neuve Brabant Wallon, BE
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Mercodia Ab
UPPSALA, SE
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Beijing Hotgen Biotech Co., Ltd.
Beijing, CN
Abbott Laboratories
Lake Forest, IL, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Ansh Labs, Llc
Webster, TX, US
510(k) clearances
10 clearances for this product code
- Tosoh Medics, Inc.Feb 13, 1996
K951848 · AIA-PACK CPR ASSAY
- Diagnostic Products Corp.Mar 23, 1995
K943767 · IMMULITE C-PEPTIDE
- Diagnostic Systems Laboratories, Inc.May 24, 1990
K896420 · DSL C-PEPTIDE RIA (DSL #7000)
- Diagnostic Products Corp.Nov 12, 1985
K854066 · DOUBLE ANTIBODY C-PEPTIDE RIA KIT
- Institut National Des RadioelementsSep 6, 1984
K842267 · C-PEP-RIA-100
- Serono Diagnostics, Inc.Apr 13, 1984
K833396 · C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
- Immuno Nuclear Corp.Jul 13, 1982
K820666 · HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
- Mallinckrodt Critical CareOct 6, 1981
K812689 · RIA QUANT C-PEPTIDE KIT