PlainRecalls

Tosoh Bioscience Inc

Compiled from official public sources by the editorial team.

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.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes

FDA Devices Moderate May 23, 2018

Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control …

FDA Devices Moderate May 23, 2018

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…

FDA Devices Moderate May 23, 2018

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…

FDA Devices Moderate May 23, 2018

Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for …

FDA Devices Moderate Mar 7, 2018

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240

FDA Devices Moderate Mar 7, 2018

ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

FDA Devices Moderate Feb 7, 2018

Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is …

FDA Devices Moderate Feb 7, 2018

Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray S…

FDA Devices Low Jun 7, 2017

AIA-PACK TPOAb CONTROL SET

FDA Devices Low Jun 7, 2017

AIA-PACK TgAb CONTROL SET

FDA Devices Moderate Mar 1, 2017

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

FDA Devices Low Aug 3, 2016

Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the pac…

FDA Devices Low Jul 22, 2015

G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution B…

FDA Devices Low Apr 17, 2013

G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

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.