Tosoh Bioscience, Inc.
Tosoh Bioscience, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2025, with 74 FDA device recalls on record.
Top product codes for Tosoh Bioscience, Inc.
FDA recalls by Tosoh Bioscience, Inc.
10 most recent of 74- Z-2746-2026 — 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
- Z-2968-2020 — 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
- Z-2967-2020 — 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
- Z-2423-2020 — AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
- Z-1420-2020 — AIA-360 Automated Immunoassay Analyzer, Product Code 019945
- Z-0672-2019 — 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.
- Z-0671-2019 — 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.
- Z-0675-2019 — 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.
- Z-0673-2019 — 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.
- Z-0676-2019 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tosoh Bioscience, Inc.
- K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
- K211199 — ST AIA-PACK BNP Assay
- K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
- K160113 — ST AIA-PACK hsE2 Calibrator Set
- K153417 — ST AIA-PACK PROG III Calibrator Set
- K150270 — ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
- K143075 — ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
- K143296 — AIA-PACK C-Peptide Control Set
- K143144 — ST AIA-PACK PROG II Calibrator Set
- K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
- K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
- K123131 — ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
- K111762 — ST AIA-PACK DHEA-S CALIBRATOR SET
- K093960 — ST AIA-PACK CYSTATIN C, MODEL 025217
- K100304 — ST AIA PACK HBA1C
- K091332 — AIA-PACK RBC FOLATE
- K071132 — G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
- K063605 — ST AIA-PACK INTACT PTH ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.