PlainRecalls

Tosoh Bioscience Inc

48 recalls on record · Latest: Sep 23, 2020

Tosoh Bioscience Inc Recall Insight

Tosoh Bioscience Inc appears on 48 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.057% 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 Sep 23, 2020, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 48 entries, severity tagging shows 0 critical, 43 moderate, and 5 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 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 (48). The date window on this page runs from Apr 17, 2013 to Sep 23, 2020.

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 Sep 23, 2020

Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Cal…

FDA Devices Moderate Sep 23, 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…

FDA Devices Moderate Jul 1, 2020

AIA-900 Analyzer, Part no. 022930, UDI 04560189283992

FDA Devices Moderate Mar 11, 2020

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

FDA Devices Moderate Jan 2, 2019

ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotr…

FDA Devices Moderate Jan 2, 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 anal…

FDA Devices Moderate Jan 2, 2019

ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparini…

FDA Devices Moderate Jan 2, 2019

ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specif…

FDA Devices Moderate Jan 2, 2019

ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (…

FDA Devices Moderate Jan 2, 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…

FDA Devices Moderate Dec 26, 2018

AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)…

FDA Devices Low Dec 19, 2018

Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quant…

FDA Devices Moderate Dec 19, 2018

AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three metho…

FDA Devices Moderate Dec 19, 2018

AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: a…

FDA Devices Moderate Dec 12, 2018

AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing …

FDA Devices Moderate Nov 28, 2018

AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoe…

FDA Devices Moderate Oct 3, 2018

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood spe…

FDA Devices Low Aug 22, 2018

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs…

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone

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 Mar 7, 2018

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

FDA Devices Low Jun 7, 2017

AIA-PACK TPOAb CONTROL SET

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.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Tosoh Bioscience Inc with FORD →

Data Sources

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