702 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
FDA Recall
Terminated
·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004
Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
FDA Recall
Terminated
·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003
Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
FDA Recall
Terminated
·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003
Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
FDA Recall
Terminated
·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004
Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.
FDA Recall
Terminated
·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
FDA Recall
Terminated
·PerkinElmer LAS Inc·Product code JIA·September 8, 2004
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 19, 2018
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 19, 2018
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·November 28, 2018
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 26, 2018
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 19, 2018
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 5, 2018
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
FDA Recall
Terminated
·Tosoh Smd Inc·Product code KHO·May 15, 2013
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JIT·August 7, 2020
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 3, 2014
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·June 10, 2015
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JJX·August 7, 2020