Legionella, Spp., Elisa
Microbiology · 21 CFR 866.3300
Recent MDR events
5 adverse event reports on file
- BINAXNOW LEGIONELLA 22T (LFR)Jan 30, 2025MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2025-00028
- BINAXNOW LEGIONELLA 22T (LFR)Feb 8, 2023DeathAbbott Diagnostics Scarborough, Inc.1221359-2023-00247
- BARTELS ELISA LEGIONELLA URINIARY ANTIGENNov 10, 2021MalfunctionTrinity Biotech, Usa1318354-2021-00003
- ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN TESTMar 1, 2019DeathAlere Scarborough Inc.1221359-2019-00013
- WESTERN BLOTJan 6, 2015InjuryMW5040150
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Trinity Biotech USAOpen, ClassifiedAug 12, 2025
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440.
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Z-2292-2025 · View FDA record ↗ - Inverness Medical Professional DiagnosticsTerminatedNov 29, 2006
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches
Z-0222-2007 · View FDA record ↗ - Clark Laboratories, Inc.TerminatedUnknown
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Leg
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Z-0382-2022 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Ssi Diagnostica A/s
Hilleroed Hovedstaden, DK
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Trinity Biotech Usa
Jamestown, NY, US
Keva Inc.
Blaine, WA, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Drg International, Inc.
Springfield, NJ, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Remel Europe Ltd
DARTFORD, KENT, GB
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US
Abbott Diagnostics Scarborough, Inc.
Westbrook, ME, US
Lumiquick Diagnostics, Inc.
SANTA CLARA, CA, US
Sa Scientific, Ltd
SAN ANTONIO, TX, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Remel, Inc.
LENEXA, KS, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
10 clearances for this product code
- Ssi Diagnostica A/SMar 5, 2020
K191184 · ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
- Meridian Bioscience, Inc.Feb 21, 2017
K163273 · TRU Legionella
- Meridian Bioscience, Inc.Feb 24, 2012
K113190 · TRU LEGIONELLA
- Sa Scientific , Ltd.Jun 28, 2007
K061496 · SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
- Inverness Medical Professional DiagnosticsMar 15, 2007
K070522 · MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
- Trinity Biotech USANov 26, 2003
K033051 · LEGIONELLA PNEUMOPHILA IGG/IGM
- Intracel Corp.Dec 21, 1999
K991074 · BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- Binax, Inc.Aug 21, 1998
K982238 · BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522