151 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Enforcement
Class III
·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
FDA Enforcement
Class II
·Terminated·Perkinelmer·August 8, 2012
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
FDA Recall
Terminated
·Perkinelmer·Product code JLW·June 27, 2012
Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 9, 2012
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
FDA Recall
Terminated
·Ergoactives, Llc·Product code IRT·January 19, 2016
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Recall
Terminated
·Battle Creek Equipment Co.·Product code IRT·September 15, 2016