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Tosoh Bioscience Inc Recalls

47 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Tosoh Bioscience Inc.

47Total Recalls
0Critical
352,787Units Affected
Aug 7, 2020Most Recent
All Recalls

Every Tosoh Bioscience Inc Recall

Sorted by most recent. Click any recall for full details.

47 recalls
High RiskFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-P...
Diagnostic Devices·39 affected·Aug 7, 2020
High RiskFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is int...
Diagnostic Devices·289 affected·Aug 7, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Medical Devices·529 affected·May 22, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Diagnostic Devices·12 affected·Jan 10, 2020
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adr...
Diagnostic Devices·1,085 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA...
Diagnostic Devices·19,366 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human ser...
Diagnostic Devices·992 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human ser...
Diagnostic Devices·26,745 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiod...
Diagnostic Devices·24,083 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human se...
Diagnostic Devices·29,645 affected·Nov 30, 2018
RecallFDA
Tosoh Bioscience Inc
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for...
Medical Devices·1,000 affected·Oct 5, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing...
Diagnostic Devices·95 affected·Sep 28, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of im...
Diagnostic Devices·395 affected·Sep 28, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay...
Diagnostic Devices·7 affected·Sep 28, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to prov...
Diagnostic Devices·1,228 affected·Aug 23, 2018
High RiskFDA
Tosoh Bioscience Inc
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in who...
Diabetes Devices·8 affected·Jul 13, 2018
RecallFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte r...
Diagnostic Devices·9 affected·Jun 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Diagnostic Devices·10,913 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Diagnostic Devices·4,027 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Diagnostic Devices·4,867 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Diagnostic Devices·4,824 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Diagnostic Devices·24,410 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Diagnostic Devices·12,614 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Diagnostic Devices·2,867 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Diagnostic Devices·9,033 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing qual...
Diagnostic Devices·2,864 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Diagnostic Devices·41,105 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Diagnostic Devices·14,690 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Diagnostic Devices·15,942 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Diagnostic Devices·5,990 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Cardiac Devices·2,549 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
Diagnostic Devices·12,361 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Diagnostic Devices·10,023 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Diagnostic Devices·1,442 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
Diagnostic Devices·43,275 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative me...
Diabetes Devices·6,049 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
Diagnostic Devices·1,047 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
Diagnostic Devices·5,491 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
Diagnostic Devices·752 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Diagnostic Devices·3,254 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Diabetes Devices·1,358 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Diagnostic Devices·49 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calib...
Diagnostic Devices·1,485 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Diagnostic Devices·3,322 affected·Feb 13, 2018
RecallFDA
Tosoh Bioscience, Inc.
AIA-PACK TPOAb CONTROL SET
Medical Devices·15 affected·Feb 8, 2017
RecallFDA
Tosoh Bioscience, Inc.
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Varia...
Medical Devices·9 affected·Feb 10, 2015
RecallFDA
Tosoh Bioscience Inc
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Medical Devices·633 affected·Aug 18, 2010