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.
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Cal…
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…
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotr…
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…
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparini…
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specif…
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (…
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…
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)…
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quant…
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three metho…
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: a…
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing …
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoe…
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood spe…
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs…
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
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…
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
AIA-PACK TPOAb CONTROL SET
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.
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