Tosoh Bioscience recalls

Tosoh Bioscience has 74 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 22 Jul 2026. 1 is still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls74since 2013

Last 12 months1reported

Class I00% of total

Ongoing1latest 22 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 1 0Aug 0 0

Severity split

Class I 0 0%Class II 67 91%Class III 7 9%

Why tosoh bioscience is recalled

Product types

By year

202611%
202111%
202045%
201968%
20185676%
201734%
201611%
201511%
201311%

Ongoing tosoh bioscience recalls

1 active

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	ST Aia-Pack Testosterone, IN Vitro Diagnostic Use Only recalled	Tosoh Bioscience	Potency & Assay	Nationwide

All tosoh bioscience recalls, newest first

74 total

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	ST Aia-Pack Testosterone, IN Vitro Diagnostic Use Only recalled	Tosoh Bioscience	Potency & Assay	Nationwide
17 Mar 2021Device	CLASS II	Thyroglobulin Antibody (TgAB) Calibrator recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
23 Sep 2020Device	CLASS II	Aia- Pack Hcg Calibrator Set-In Vitro Diagnostic for Bhcg recalled	Tosoh Bioscience	Potency & Assay	Nationwide
23 Sep 2020Device	CLASS II	Aia-pack Bhcg Calibration Verification Test Set-In Vitro recalled	Tosoh Bioscience	Potency & Assay	Nationwide
1 Jul 2020Device	CLASS II	AIA-900 Analyzer recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
11 Mar 2020Device	CLASS II	AIA-360 Automated Immunoassay Analyzer, Product recalled	Tosoh Bioscience	Device Malfunction	5 states
2 Jan 2019Device	CLASS II	Aia-pack B12 (Vitamin B12) is designed recalled by Tosoh Bioscience	Tosoh Bioscience	Labeling Errors	Nationwide
2 Jan 2019Device	CLASS II	ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed recalled	Tosoh Bioscience	Other	Nationwide
2 Jan 2019Device	CLASS II	ST Aia-pack Testosterone (Tes) is designed recalled by Tosoh Bioscience	Tosoh Bioscience	Other	Nationwide
2 Jan 2019Device	CLASS II	ST Aia-pack Homocysteine (Hcy) is designed recalled by Tosoh Bioscience	Tosoh Bioscience	Other	Nationwide
2 Jan 2019Device	CLASS II	Aia-pack Folate (Fol) is designed recalled by Tosoh Bioscience	Tosoh Bioscience	Other	Nationwide
2 Jan 2019Device	CLASS II	ST Aia-pack Acth (Acth: Adrenocorticotropic Hormone) recalled	Tosoh Bioscience	Other	Nationwide
26 Dec 2018Device	CLASS II	AIA-360 Analyzer is capable of performing two methods recalled	Tosoh Bioscience	Device Malfunction	Nationwide
19 Dec 2018Device	CLASS II	AIA-900 Automated Immunoassay Analyzer performs three recalled	Tosoh Bioscience	Device Malfunction	Nationwide
19 Dec 2018Device	CLASS II	AIA-900Analyzer, Product recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
19 Dec 2018Device	CLASS II	AIA-2000 Analyzer, Product recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
19 Dec 2018Device	CLASS III	Hemoglobin A1c Control recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
12 Dec 2018Device	CLASS II	AIA-360 Analyzer, product recalled by Tosoh Bioscience	Tosoh Bioscience	Device Malfunction	Nationwide
5 Dec 2018Device	CLASS II	AIA-900 Automated Immunoassay Analyzer, product recalled	Tosoh Bioscience	Potency & Assay	Nationwide
28 Nov 2018Device	CLASS II	Tosoh AIA-900 immunoassay Analyzer recalled by Tosoh Bioscience	Tosoh Bioscience	Device Malfunction	GA, NY
28 Nov 2018Device	CLASS II	AIA-2000 Analyzer recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
21 Nov 2018Device	CLASS II	AIA-900 Analyzer, Product recalled by Tosoh Bioscience	Tosoh Bioscience	Device Malfunction	Nationwide
3 Oct 2018Device	CLASS II	G8 Automated HPLC Analyzer - 723G8 recalled by Tosoh Bioscience	Tosoh Bioscience	Device Malfunction	Nationwide
22 Aug 2018Device	CLASS II	G8 Automated Hplc Analyzer: Hlc-723G8-ST recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
22 Aug 2018Device	CLASS III	AIA Analyte Application Manual (AAM) CD recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	6 states
13 Jun 2018Device	CLASS II	St-aia Pack Iri recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
13 Jun 2018Device	CLASS II	Aia-pack TSH 3rd Generation recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
13 Jun 2018Device	CLASS II	St-aia Pack Shbg recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
13 Jun 2018Device	CLASS II	St-aia Pack Myoglobin recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide
13 Jun 2018Device	CLASS II	St-aia Pack Hcg recalled by Tosoh Bioscience	Tosoh Bioscience	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.