Tosoh Bioscience Inc
Grove City, OH
This page shows every FDA and USDA recall linked to Tosoh Bioscience Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
67
Total Recalls
2012
First Recall
2020
Most Recent
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG
Part number 020361
The AIA-Pack...
Sep 14, 2020
· Device
Terminated
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy
Part...
Sep 14, 2020
· Device
Terminated
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
May 22, 2020
· Device
Terminated
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Feb 11, 2020
· Device
Terminated
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative...
Nov 30, 2018
· Device
Terminated
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quan...
Nov 30, 2018
· Device
Terminated
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement o...
Nov 30, 2018
· Device
Terminated
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement o...
Nov 30, 2018
· Device
Terminated
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate...
Nov 30, 2018
· Device
Terminated
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vi...
Nov 30, 2018
· Device
Terminated
AIA-900 Analyzer, Product code 022930, 022930R
Oct 5, 2018
· Device
Terminated
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R
Product Usage:
The AIA-900 is capable of...
Oct 5, 2018
· Device
Terminated
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of labora...
Oct 5, 2018
· Device
Terminated
AIA-900Analyzer, Product code 022930, 022930R
The AIA-2000 analyzer and AIA-900 analyzer are capable of perfo...
Sep 28, 2018
· Device
Terminated
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing t...
Sep 28, 2018
· Device
Terminated
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R
The AIA-2000 analyzer and AIA-900 analyzer...
Sep 28, 2018
· Device
Terminated
Tosoh AIA-900 immunoassay Analyzer
Sep 28, 2018
· Device
Terminated
AIA-360 Analyzer, product code 019945/019945R
The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in...
Aug 23, 2018
· Device
Terminated
G8 Automated HPLC Analyzer - 723G8
Product Usage - In vitro diagnostic use for the quantitative measurement o...
Jul 13, 2018
· Device
Terminated
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674
Product Usage:
The Tosoh Automated...
Jun 6, 2018
· Device
Terminated
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD
Part Number: 997027
CD contains analyte application...
Jun 5, 2018
· Device
Terminated
ST-AIA PACK HGH; Part Number: 025266
Assay, Metabolic
Mar 5, 2018
· Device
Terminated
ST-AIA PACK TU; Part Number: 025270
Assay, Thyroid
Mar 5, 2018
· Device
Terminated
ST-AIA PACK CEA; Part Number: 025254
Assay, Tumor Marker
Mar 5, 2018
· Device
Terminated
ST-AIA PACK C-Peptide II; Part Number: 025283
Assay, Diabetes
Mar 5, 2018
· Device
Terminated
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318
The product is intended for In Vitro Diagnost...
Mar 5, 2018
· Device
Terminated
AIA-PACK TSH 3rd Generation; Part Number: 020294
Assay, Thyroid
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Prolactin; Part Number: 025255
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK TT3; Part Number: 025282
Assay, Thyroid
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Estradiol; Part Number: 025274
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK AFP; Part Number: 025252
Assay, Tumor Marker
Mar 5, 2018
· Device
Terminated
ST-AIA PACK SHBG; Part Number: 025238
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Cort; Part Number: 025287
Assay, Metabolic
Mar 5, 2018
· Device
Terminated
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418
The product is intended for In Vitro Diagnostic Use...
Mar 5, 2018
· Device
Terminated
ST-AIA PACK IGE II; Part Number: 025295
Assay, Allergy
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Fer; Part Number: 025253
Assay, Anemia
Mar 5, 2018
· Device
Terminated
ST-AIA PACK C-Peptide; Part Number: 025284
Assay, Diabetes
Mar 5, 2018
· Device
Terminated
ST-AIA PACK T4; Part Number: 025258
Assay, Thyroid
Mar 5, 2018
· Device
Terminated
ST-AIA PACK FT3; Part Number: 025286
Assay, Thyroid
Mar 5, 2018
· Device
Terminated
ST-AIA PACK HCG; Part Number: 025256
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK CK-MB; Part Number: 025269
Assay, Cardiac Marker
Mar 5, 2018
· Device
Terminated
ST-AIA PACK cTnI 2nd Gen; Part Number: 025205
Assay, Cardiac Marker
Mar 5, 2018
· Device
Terminated
ST-AIA DHEA-S; Part Number: 025222
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK BMG; Part Number:025259
Assay, Tumor Marker
Mar 5, 2018
· Device
Terminated
ST-AIA PACK FSH; Part Number: 025265
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Prog II; Part Number: 025239
Assay, Reproductive Hormone
Mar 5, 2018
· Device
Terminated
ST-AIA PACK IRI; Part Number: 025260
Assay, Diabetes
Mar 5, 2018
· Device
Terminated
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218
The device is designed for In Vitro Diagnostic Use Onl...
Mar 5, 2018
· Device
Terminated
ST-AIA PACK CA 19-9; Part Number: 025271
Assay, Tumor Marker
Mar 5, 2018
· Device
Terminated
ST-AIA PACK Cystatin C; Part Number: 025217
Assay, Kidney Marker
Mar 5, 2018
· Device
Terminated