Iga, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510
Recent MDR events
11 adverse event reports on file
- TINA-QUANT IGA GEN.2May 13, 2026MalfunctionRoche Diagnostics1823260-2026-01891
- TINA-QUANT IGA GEN.2May 7, 2025MalfunctionRoche Diagnostics1823260-2025-01406
- TINA-QUANT IGA GEN.2Dec 4, 2024MalfunctionRoche Diagnostics1823260-2024-03514
- TINA-QUANT IGA GEN.2Jul 23, 2024MalfunctionRoche Diagnostics1823260-2024-02119
- IGA-2May 3, 2022MalfunctionRoche Diagnostics1823260-2022-01254
- IGA GEN.2, COBAS C503Aug 9, 2021MalfunctionRoche Diagnostics1823260-2021-02316
- COBAS INTEGRA IGA GEN 2May 22, 2017MalfunctionRoche Diagnostics1823260-2017-01060
- COBAS INTEGRA IGA GEN 2Dec 19, 2016MalfunctionRoche Diagnostics1823260-2016-02006
- COBAS INTEGRA IGA GEN 2Jun 23, 2016MalfunctionRoche Diagnostics1823260-2016-00802
- ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Aug 20, 2015MalfunctionRoche Diagnostics1823260-2015-04001
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Randox Laboratories Ltd.TerminatedDec 3, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma
Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
Z-0362-2023 · View FDA record ↗ - Roche Diagnostics CorporationTerminatedUnknown
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is meas
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Z-1979-2019 · View FDA record ↗ - Abbott Laboratories, IncTerminatedUnknown
Immunoglobulin A 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-1988-2019 · View FDA record ↗
Registered firms
34 firms currently registered for this product code
Beckman Coulter, Inc.
BREA, CA, US
Abbott Gmbh
Wiesbaden Hesse, DE
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Diamond Diagnostics Inc.
Budapest, HU
Abbott Laboratories
Lake Forest, IL, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Agilent Technologies Inc.
Cedar Creek, TX, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Beckman Coulter, Inc.
CARLSBAD, CA, US
Horiba Abx Sas
MONTPELLIER Herault, FR
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Bit Analytical Solutions Gmbh
SCHWALBACH/TAUNUS Hesse, DE
510(k) clearances
54 clearances for this product code
- HORIBA ABX SASJun 26, 2020
K193525 · Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- Beckman Coulter, Inc.Feb 13, 2006
K060130 · IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- Roche Diagnostics Corp.Mar 10, 2004
K040435 · ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- Dade Behring, Inc.Feb 13, 2003
K024038 · N LATEX IGA
- Wako Chemicals USA, Inc.Jan 14, 2000
K993927 · WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- Abbott LaboratoriesNov 4, 1998
K983359 · IGA
- Instrumentation Laboratory COSep 25, 1996
K962200 · QUANTEX IGA
- Randox Laboratories, Ltd.Apr 5, 1996
K955794 · IGA IMMUNOTURBIDIMETRIC & CALIBRATOR