Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5100
Recent MDR events
1 adverse event reports on file
Recalls
7 recall events for this product code
- Inova Diagnostics IncorporatedTerminatedNov 23, 2011
Inova Diagnostic Inc., NOVA Lite ANA KSL Kit
The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume.
Z-0280-2012 · View FDA record ↗ - Bio-Rad LaboratoriesTerminatedAug 22, 2011
"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN"
KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
Z-3051-2011 · View FDA record ↗ - Immuno Concepts IncTerminatedApr 6, 2009
ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4
Samples can occasionally run out of the wells and cross contaminate adjacent wells.
Z-1044-2009 · View FDA record ↗ - Bio-Rad LaboratoriesTerminatedSep 19, 2008
Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED
The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Z-2429-2008 · View FDA record ↗ - Diasorin Inc.TerminatedMay 10, 2005
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Tes
A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.
Z-0807-05 · View FDA record ↗ - Diasorin Inc.TerminatedApr 6, 2005
PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin AN
The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
Z-0676-05 · View FDA record ↗ - Perkinelmer Life Sciences, Inc.TerminatedAug 20, 2003
Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use
Product's outer carton label was labeled with an extended expiration date
Z-1140-03 · View FDA record ↗
Registered firms
74 firms currently registered for this product code
Zeus Scientific Llc
BRANCHBURG, NJ, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Aesku.diagnostics Gmbh&co.kg
WENDELSHEIM Rhineland-Palatinate, DE
Immuno Concepts, Na, Ltd.
SACRAMENTO, CA, US
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Diasorin Inc.
Stillwater, MN, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Phadia Us Inc.
Portage, MI, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Bio-rad Laboratories Inc.
Irvine, CA, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Immco Diagnostics, Inc.
Williamsville, NY, US
Bio-rad Laboratories Inc.
IRVINE, CA, US
510(k) clearances
110 clearances for this product code
- Zeus Scientific, Inc.Apr 29, 2022
K201956 · Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- Immco Diagnostics, Inc.Jun 5, 2018
K172745 · ImmuGlo HEp-2 Elite IFA
- Aesku Systems GmbH&Co.KgJul 28, 2016
K153117 · AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- Immuno Concepts, N.A. , Ltd.Jun 17, 2016
K160265 · Image Navigator by Immuno Concepts
- Euroimmun Us, Inc.Apr 17, 2015
K141827 · EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
- Inova Diagnostics, Inc.Apr 8, 2015
K150155 · NOVA Lite DAPI ANA Kit
- Euroimmun USFeb 26, 2014
K131791 · IFA 40: HEP-20-10
- Aesku DiagnosticsOct 15, 2012
K120889 · AESKUSLIDES ANA HEP-2