Tosoh Bioscience Inc
FDA Regulatory Profile
Tosoh Bioscience Inc appears in FDA public data with 74 recalls, 20 510(k) clearances, 8 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2746-2026, Class II) was initiated on June 12, 2026. Its most recent 510(k) clearance was granted on October 3, 2025.
Summary
- Total Recalls
- 74
- 510(k) Clearances
- 20
- Inspections
- 8
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2746-2026 | Class II | ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testoster | June 12, 2026 |
| Z-2967-2020 | Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 Th | August 7, 2020 |
| Z-2968-2020 | Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregna | August 7, 2020 |
| Z-2423-2020 | Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | May 22, 2020 |
| Z-1420-2020 | Class II | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | January 10, 2020 |
| Z-0674-2019 | Class II | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative mea | November 30, 2018 |
| Z-0676-2019 | Class II | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY fo | November 30, 2018 |
| Z-0672-2019 | Class II | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement | November 30, 2018 |
| Z-0671-2019 | Class II | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measure | November 30, 2018 |
| Z-0673-2019 | Class II | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu | November 30, 2018 |
| Z-0675-2019 | Class II | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative mea | November 30, 2018 |
| Z-0469-2019 | Class II | AIA-900 Analyzer, Product code 022930, 022930R | October 5, 2018 |
| Z-0509-2019 | Class II | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 | October 5, 2018 |
| Z-0601-2019 | Class III | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision | October 5, 2018 |
| Z-0600-2019 | Class II | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capa | September 28, 2018 |
| Z-0475-2019 | Class II | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of pe | September 28, 2018 |
| Z-0485-2019 | Class II | Tosoh AIA-900 immunoassay Analyzer | September 28, 2018 |
| Z-0599-2019 | Class II | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-9 | September 28, 2018 |
| Z-0559-2019 | Class II | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer i | August 23, 2018 |
| Z-3244-2018 | Class II | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative m | July 13, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | October 3, 2025 |
| K211199 | ST AIA-PACK BNP Assay | November 8, 2021 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | August 5, 2021 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | February 17, 2016 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | December 18, 2015 |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Co | October 26, 2015 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | July 2, 2015 |
| K143296 | AIA-PACK C-Peptide Control Set | December 16, 2014 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | December 3, 2014 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | April 10, 2014 |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | January 23, 2014 |
| K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CO | February 8, 2013 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | June 15, 2012 |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | December 1, 2011 |
| K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET | August 5, 2011 |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | September 14, 2010 |
| K100304 | ST AIA PACK HBA1C | August 27, 2010 |
| K091332 | AIA-PACK RBC FOLATE | October 2, 2009 |
| K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | September 16, 2008 |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | June 21, 2007 |