Tosoh Bioscience Inc
48 recalls on record · Latest: Sep 23, 2020
FDA Devices Moderate Sep 23, 2020
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Cal…
FDA Devices Moderate Sep 23, 2020
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…
FDA Devices Moderate Jul 1, 2020
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
FDA Devices Moderate Mar 11, 2020
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
FDA Devices Moderate Jan 2, 2019
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotr…
FDA Devices Moderate Jan 2, 2019
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System anal…
FDA Devices Moderate Jan 2, 2019
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparini…
FDA Devices Moderate Jan 2, 2019
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specif…
FDA Devices Moderate Jan 2, 2019
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (…
FDA Devices Moderate Jan 2, 2019
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh…
FDA Devices Moderate Dec 26, 2018
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)…
FDA Devices Low Dec 19, 2018
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quant…
FDA Devices Moderate Dec 19, 2018
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three metho…
FDA Devices Moderate Dec 19, 2018
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: a…
FDA Devices Moderate Dec 12, 2018
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing …
FDA Devices Moderate Nov 28, 2018
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoe…
FDA Devices Moderate Oct 3, 2018
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood spe…
FDA Devices Low Aug 22, 2018
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs…
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
FDA Devices Moderate May 23, 2018
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control …
FDA Devices Moderate May 23, 2018
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement fo…
FDA Devices Moderate May 23, 2018
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of th…
FDA Devices Moderate Mar 7, 2018
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
FDA Devices Low Jun 7, 2017
AIA-PACK TPOAb CONTROL SET
FDA Devices Low Jul 22, 2015
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution B…
FDA Devices Low Apr 17, 2013