Tosoh Bioscience Inc
73 recalls on record · Latest: Mar 17, 2021
Tosoh Bioscience Inc Recall Insight
Tosoh Bioscience Inc appears on 73 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.072% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 17, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 23 entries, severity tagging shows 0 critical, 18 moderate, and 5 lower-severity recalls. Affected-unit counts are disclosed on 23 of 23 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (23). The date window on this page runs from Apr 17, 2013 to Jun 13, 2018.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control …
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement fo…
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of th…
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for …
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is …
Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray S…
AIA-PACK TPOAb CONTROL SET
AIA-PACK TgAb CONTROL SET
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the pac…
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution B…
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.