Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Microbiology · 21 CFR 866.3380
Recent MDR events
7 adverse event reports on file
- VIDAS® MUMPS IGG ASSAYFeb 21, 2018MalfunctionBiomerieux, Sa3002769706-2018-00018
- PROGRAMMING SOFTWAREMay 19, 2016MalfunctionCyberonics - Houston1644487-2016-01069
- PROGRAMMING SOFTWAREMay 16, 2016MalfunctionCyberonics - Houston1644487-2016-01024
- VIDAS® MUMPS IGGFeb 24, 2016MalfunctionBiomerieux Sa3002769706-2016-00039
- VIDAS® MUMPS IGG ASSAYJan 13, 2016MalfunctionBiomerieux Sa3002769706-2016-00009
- VIDAS® MUMPS IGG ASSAYJan 13, 2016MalfunctionBiomerieux Sa3002769706-2016-00008
- BARDPORT IMPLANTED PORTNov 14, 1996InjuryBard Access Systems50241
Event type breakdown
Most-reported manufacturers
Recalls
7 recall events for this product code
- Bion Enterprises LtdTerminatedJun 5, 2013
Plastic bottle containing 3.5 mL of IgG FITC Conjugate
Affected products have a labeled expiration date of one year too long.
Z-1479-2013 · View FDA record ↗ - Zeus Scientific, Inc.TerminatedMay 8, 2012
AtheNA Multi-Lyte MMV Test System- A93111G
Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps.
Z-1500-2012 · View FDA record ↗ - Calbiotech IncTerminatedMar 5, 2010
Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G
The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0999-2010 · View FDA record ↗ - Diasorin Inc.TerminatedFeb 23, 2006
The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated plat
Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.
Z-0557-06 · View FDA record ↗ - bioMerieux, Inc.Open, ClassifiedUnknown
VIDAS Mumps IgG (MPG), REF 30218
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Z-0429-2022 · View FDA record ↗ - Diamedix CorporationTerminatedUnknown
Diamedix Is-Mumps IgG Test Kit
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Z-1685-2016 · View FDA record ↗ - Diamedix CorporationTerminatedUnknown
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Contains a gel-like contaminant that may affect product performance.
Z-2573-2018 · View FDA record ↗
Registered firms
26 firms currently registered for this product code
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Trinity Biotech Usa
Jamestown, NY, US
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Gold Standard Diagnostics, Llc
Davis, CA, US
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Immuno-biological Laboratories, Inc.
Fridley, MN, US
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
Calbiotech, Inc.
El Cajon, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Ups Supply Chain Solutions, Inc.
Pedricktown, NJ, US
Drg International, Inc.
Springfield, NJ, US
Diesse Diagnostica Senese S.p.a
MONTERIGGIONI Siena, IT
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Ups Supply Chain Solutions, Inc.
Mira Loma, CA, US
Biomerieux Sa
MARCY L ETOILE Rhone, FR
Drg Instruments Gmbh
MARBURG Hesse, DE
510(k) clearances
8 clearances for this product code
- Columbia Bioscience, Inc.Sep 3, 1999
K991274 · MUMPS IGG ELISA TEST SYSTEM
- Quest Intl., Inc.Apr 23, 1998
K980059 · SERAQUEST MUMPS IGG
- Gull Laboratories, Inc.Nov 4, 1997
K971857 · MUMPS IGG ELISA TESTY
- Zeus Scientific, Inc.Jul 18, 1996
K961204 · MUMPS IGG TEST
- Biowhittaker Molecular Applications, Inc.Oct 14, 1994
K925209 · MUMPS STAT
- Biomerieux Vitek, Inc.Aug 9, 1993
K923903 · VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
- Pharmacia Eni Diagnostics, Inc.Jul 26, 1990
K897006 · PHARMACIA MUMPS IGG ELISA
- M.A. BioproductsMay 13, 1983
K830045 · MUMPSELISA TEST KIT