Tosoh Bioscience Inc
74 recalls on record · Latest: Jul 22, 2026
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Agency notice ledger
Federal filing book Tosoh Bioscience Inc MID-BOOK · SINGLE-AGENCY
#242 of 14,151 · 74 notices · 0.071% archive
- BOOK 74 notices
- RANK #242 of 14,151
- SHARE 0.071% archive
- AGENCY FDA Devices (74)
- CAT medical devices
- CATS 1 category
- LATEST Jul 22, 2026
- PHOTO Publix Super Markets,…
Nearest notice-volume peer: Publix Super Markets, Inc. (0 notice gap)
Tosoh Bioscience Inc accounts for about 0.071% of the 104,423-notice archive on 74 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Tosoh Bioscience Inc compares to 14,151 recalling firms
Tosoh Bioscience Inc ranks 242nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Tosoh Bioscience Inc vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
74 242nd of 14151 higher than 13,909 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Tosoh Bioscience Inc in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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Tosoh Bioscience Inc
74 notices
- Publix Super…
Publix Super Markets, Inc.
74 notices
What this shows Tosoh Bioscience Inc holds about 0.071% of archive notices alongside 74 distinct filings.
FDA Devices Moderate Jul 22, 2026
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
FDA Devices Moderate Mar 17, 2021
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
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 Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
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 VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
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 Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.
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 analyzers.
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, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
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 specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
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 (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
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 AIA System analyzers.
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) 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.
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 quantitation.
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 methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
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: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Devices Moderate Dec 19, 2018
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.
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 for a broad menu of assays in a unique patented dry reagent format.
FDA Devices Moderate Dec 5, 2018
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.
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 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.
FDA Devices Moderate Nov 28, 2018
Tosoh AIA-900 immunoassay Analyzer
FDA Devices Moderate Nov 21, 2018
AIA-900 Analyzer, Product code 022930, 022930R
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 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.
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 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.
FDA Devices Moderate Aug 22, 2018
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.
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 Jun 13, 2018
ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
FDA Devices Moderate Jun 13, 2018
ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
Tosoh Bioscience Inc carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (74 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Tosoh Bioscience Inc? ▼
PlainRecalls indexes 74 distinct federal recall events naming Tosoh Bioscience Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Tosoh Bioscience Inc sit among other recalling firms? ▼
Tosoh Bioscience Inc ranks #242 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Tosoh Bioscience Inc's notices? ▼
FDA Devices accounts for 74 of this firm's 74 indexed notices.
What product category dominates Tosoh Bioscience Inc's filing book? ▼
Filings for Tosoh Bioscience Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Tosoh Bioscience Inc: 74 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Tosoh Bioscience Inc; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026