Tosoh Bioscience Inc: Medical Device Recalls in 2018

According to to data from the FDA, there were 56 medical device recalls made by Tosoh Bioscience Inc in 2018. See the details of the recalls below.

You can see similar recalls for other firms.

• Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
• Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
• G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
• 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.
• Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
• Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
• Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
• Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
• AIA-900 Analyzer, Product code 022930, 022930R
• Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
• G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
• ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
• ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
• ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
• ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
• ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
• ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
• ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
• ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
• ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
• AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
• ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
• ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
• ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
• ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
• ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
• ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
• ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
• ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
• ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
• ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
• ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
• ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
• ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
• ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
• ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
• ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
• ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
• ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
• ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
• ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
• Tosoh AIA-900 immunoassay Analyzer
• 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.
• 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.
• 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.
• ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
• ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
• 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.
• ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
• ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
• ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
• ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
• ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
• 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.
• Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
• 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.