Igg, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510
Recent MDR events
71 adverse event reports on file
- BN II SYSTEMJun 16, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00018
- TINA-QUANT IGG GEN.2May 27, 2026MalfunctionRoche Diagnostics1823260-2026-02082
- BN II SYSTEMDec 19, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00061
- TINA-QUANT IGG CSFJun 13, 2024MalfunctionRoche Diagnostics1823260-2024-01763
- BN II SYSTEMApr 19, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00005
- BN II SYSTEMJan 18, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00001
- BN II SYSTEMAug 24, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00012
- VIDAS ANALYSERDec 30, 2020MalfunctionBiomerieux Italia S.p.a.9615037-2020-00040
- VIDAS ANALYSERDec 30, 2020MalfunctionBiomerieux Italia S.p.a.9615037-2020-00039
- VIDAS ANALYSERDec 30, 2020MalfunctionBiomerieux Italia S.p.a.9615037-2020-00038
Event type breakdown
Recalls
4 recall events for this product code
- Beckman Coulter Inc.Open, ClassifiedOct 17, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Z-0118-2025 · View FDA record ↗ - Beckman Coulter Inc.TerminatedSep 30, 2010
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M902345. Using these reagent lots, some samples deficient in IgA have yielded results in the normal range. Other samples with normal levels of IgA have yielded falsely high results.
Z-2653-2010 · View FDA record ↗ - Beckman Coulter IncTerminatedJul 23, 2004
IMMAGE IgM Reagent
low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.
Z-1150-04 · View FDA record ↗ - Abbott Laboratories, IncTerminatedUnknown
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of
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-1989-2019 · View FDA record ↗
Registered firms
40 firms currently registered for this product code
Agilent Technologies Inc.
Cedar Creek, TX, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Kent Laboratories, Inc.
BELLINGHAM, WA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Beckman Coulter, Inc.
CARLSBAD, CA, US
Abbott Ireland Diagnostics Division
Longford, IE
Zeus Scientific Llc
BRANCHBURG, NJ, US
Diamond Diagnostics Inc.
Budapest, HU
Biomerieux Sa
LA BALME LES GROTTES Isere, FR
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Kamiya Biomedical Company Llc
Tukwila, WA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Beckman Coulter, Inc.
BREA, CA, US
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
510(k) clearances
76 clearances for this product code
- Roche Diagnostics Corp.Feb 8, 2005
K050113 · TINA-QUANT IGG GEN.2
- Roche Diagnostics Corp.Mar 10, 2004
K040434 · ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
- Helena LaboratoriesMar 15, 2001
K010617 · SPIFE IFE CALIBRATOR AND CONTROL KIT
- Wako Chemicals USA, Inc.Jan 18, 2000
K993928 · WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- Kamiya Biomedical Co.Nov 9, 1999
K993281 · K-ASSAY IGG
- Abbott LaboratoriesNov 4, 1998
K983221 · IGG
- Beckman Instruments, Inc.Mar 6, 1997
K965108 · SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
- Beckman Instruments, Inc.Mar 6, 1997
K963974 · IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN