Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Tosoh CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Tosoh Bioscience with 74 device recalls and 20 510(k) clearances. The most recent is a 510(k) clearance dated Oct 3, 2025: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 3, 2025 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01K250073 · PDJ | 510(k) clearances |
| Nov 8, 2021 | ST AIA-PACK BNP AssayK211199 · NBC | 510(k) clearances |
| Aug 5, 2021 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8K200904 · PDJ | 510(k) clearances |
| Feb 8, 2017 | AIA-PACK TPOAb CONTROL SETClass III · The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the | Device recalls |
| Feb 8, 2017 | AIA-PACK TgAb CONTROL SETClass III · The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the | Device recalls |
| Nov 7, 2016 | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.Class II · The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemog | Device recalls |
| Jun 7, 2016 | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included iClass III · Instructions For Use had incorrect lot number and calibrator values | Device recalls |
| Feb 17, 2016 | ST AIA-PACK hsE2 Calibrator SetK160113 · JIT | 510(k) clearances |
| Dec 18, 2015 | ST AIA-PACK PROG III Calibrator SetK153417 · JIT | 510(k) clearances |
| Oct 26, 2015 | 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 SetK150270 · MRG | 510(k) clearances |
| Jul 2, 2015 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetK143075 · CDZ | 510(k) clearances |
| Feb 10, 2015 | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Class III · The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct | Device recalls |
| Dec 16, 2014 | AIA-PACK C-Peptide Control SetK143296 · JJX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
