154 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
FDA Recall
Terminated
·Tosoh Bioscience, Inc.·Product code JPK·August 18, 2005
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
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
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·August 23, 2018
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 Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 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 Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 2018
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CEP·March 5, 2018
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LTJ·March 5, 2018
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code MOI·March 5, 2018
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CHP·March 5, 2018
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NDY·March 5, 2018
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NIG·March 5, 2018
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JLS·March 5, 2018
ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DDR·March 5, 2018
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CGJ·March 5, 2018
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CEC·March 5, 2018
ST-AIA PACK HCG; Part Number: 025261 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JHI·March 5, 2018
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018
ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JFH·March 5, 2018
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JFT·March 5, 2018