Stainer, Tissue, Automated
Pathology · 21 CFR 864.3800
Recent MDR events
24 adverse event reports on file
- VP2000 PROCESSORMar 3, 2023MalfunctionAbbott Molecular, Inc.3005248192-2023-00119
- ABBOTT VP 2000 PROCESSOROct 15, 2018MalfunctionAbbott Molecular, Inc.3005248192-2018-00014
- UNKNOWN HIP FEMORAL STEMApr 9, 2018InjuryDepuy Orthopaedics Inc Us1818910-2018-56914
- VP 2000 PROCESSORApr 15, 2016MalfunctionAbbott Molecular, Inc.3005248192-2016-00002
- VP 2000 PROCESSORMar 25, 2016MalfunctionAbbott Molecular, Inc.3005248192-2016-00001
- VP 2000 PROCESSORSep 17, 2015MalfunctionAbbott Molecular, Inc.3005248192-2015-00019
- VP 2000 PROCESSORNov 12, 2014MalfunctionAbbott Molecular, Inc.3005248192-2014-00073
- VP 2000 PROCESSORNov 12, 2014MalfunctionAbbott Molecular, Inc.3005248192-2014-00074
- VP 2000 PROCESSOROct 27, 2014MalfunctionAbbott Molecular, Inc.3005248192-2014-00068
- VP 2000 PROCESSOROct 3, 2014MalfunctionAbbott Molecular, Inc.3005248192-2014-00061
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Biogenex LaboratoriesTerminatedMar 8, 2010
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B;
Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
Z-1016-2010 · View FDA record ↗ - Abbott MolecularTerminatedAug 30, 2009
VP 2000 Processor; an automated tissue stainer
Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor.
Z-1929-2009 · View FDA record ↗ - Biogenex LaboratoriesTerminatedAug 22, 2008
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
Z-1471-2008 · View FDA record ↗ - Ventana Medical Systems IncTerminatedJan 25, 2008
Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.
Z-0553-2008 · View FDA record ↗ - Ventana Medical Systems IncTerminatedJan 9, 2008
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.
Z-0300-2008 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Especialidades Medicas Myr Sl
Llorenc del Pendes Tarragona, ES
Wuhan Landing Intelligence Medical Co.,ltd
Wuhan Hubei, CN
Millennium Surgical Corp
Schaumburg, IL, US
Biogenex Laboratories Inc.
Fremont, CA, US
Milestone S.p.a.
Sorisole Bergamo, IT
Mercedes Medical Llc
Lakewood Ranch, FL, US
Ted Pella, Inc.
REDDING, CA, US
Volusol
Tooele, UT, US
Springside Scientific Llc
Durham, NC, US
Slee Medical Gmbh
Nieder-Olm Rhineland-Palatinate, DE
Auxein Medical Private Limited
Sonipat Haryana, IN
Win Wings Corp.
SIALKOT Punjab, PK
Abbott Molecular, Inc.
Des Plaines, IL, US
510(k) clearances
1 clearances for this product code