The Recall Desk

Manufacturer

Tosoh Bioscience, Inc.

74 recalls in our database name Tosoh Bioscience, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
74
Critical
0
Severe
0
Most recent
2026-07-22

Of the 74 recalls from Tosoh Bioscience, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 74

  • ModerateFDA (Devices)·Z-2746-2026·2026-07-22

    Tosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall

    Tosoh Bioscience is recalling ST AIA-Pack Testosterone test kits due to low-quality control results that could produce falsely elevated or falsely low testosterone measurements, potentially leading to unnecessary testing or delayed diagnosis.

    Product
    ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1187-2021·2021-03-17

    Tosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures

    Tosoh Bioscience Inc is recalling specific lots of Thyroglobulin Antibody Calibrators because some combinations with AIA PACKS resulted in unacceptable calibration values.

    Product
    Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues

    Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.

    Product
    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues

    Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.

    Product
    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 VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2020·2020-03-11

    Tosoh AIA-360 Analyzer Recalled Due to Display Screen Software Freeze

    Tosoh Bioscience Inc is recalling 12 AIA-360 Automated Immunoassay Analyzers because a software issue causes the display to freeze and stop the instrument.

    Product
    AIA-360 Automated Immunoassay Analyzer, Product Code 019945
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0673-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

    Product
    ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2019·2019-01-02

    Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

    Product
    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 analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0674-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

    Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.

    Product
    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK ACTH In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.

    Product
    ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain dis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0675-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Homocysteine Diagnostic Reagents

    Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.

    Product
    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hype
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0671-2019·2019-01-02

    Tosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference

    Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.

    Product
    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 System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2019·2018-12-26

    Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction

    Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.

    Product
    AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0600-2019·2018-12-19

    Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk

    Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.

    Product
    AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0599-2019·2018-12-19

    Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage

    Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.

    Product
    AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2019·2018-12-19

    Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear

    Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0601-2019·2018-12-19

    Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation

    Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.

    Product
    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2019·2018-12-12

    Tosoh AIA-360 Analyzer Recalled for Labeling Clarifications on Maintenance Requirements

    Tosoh Bioscience is recalling 1,228 AIA-360 Analyzers to update labeling and training materials regarding maintenance and reagent requirements.

    Product
    AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2019·2018-12-05

    Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure

    Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2019·2018-11-28

    Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect

    Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.

    Product
    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0485-2019·2018-11-28

    Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing

    Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.

    Product
    Tosoh AIA-900 immunoassay Analyzer
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0469-2019·2018-11-21

    Tosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction

    Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.

    Product
    AIA-900 Analyzer, Product code 022930, 022930R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3244-2018·2018-10-03

    Tosoh G8 Automated HPLC Analyzer Recalled for Missing 510(k) Software

    Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).

    Product
    G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2018·2018-08-22

    Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference

    Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.

    Product
    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2827-2018·2018-08-22

    Tosoh Bioscience Recalls AIA Analyte Application Manual CDs

    Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.

    Product
    Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference sect
    Category
    Medical Device
    Distribution
    6 states