Tosoh Bioscience Inc
Grove City, OH, US
TOSOH BIOSCIENCE, INC. appears in FDA device records in Grove City, OH. FDA records list 20 510(k) clearances between and , 10 PMA records and one registered establishment. As of , FDA records show 84 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Tosoh Bioscience Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Tosoh Smd Incenforcement report, recall
510(k) clearance history
FDA records hold 20 510(k) clearances for Tosoh Bioscience Inc between 2007 and 2025. The busiest year on record is 2014, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 1 |
| 2021 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | PDJ | Substantially Equivalent | |
| K211199 | ST AIA-PACK BNP Assay | NBC | Substantially Equivalent | |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | PDJ | Substantially Equivalent | |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | JIT | Substantially Equivalent | |
| K153417 | ST AIA-PACK PROG III Calibrator Set | JIT | Substantially Equivalent | |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | MRG | Substantially Equivalent | |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | CDZ | Substantially Equivalent | |
| K143296 | AIA-PACK C-Peptide Control Set | JJX | Substantially Equivalent | |
| K143144 | ST AIA-PACK PROG II Calibrator Set | JIT | Substantially Equivalent | |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | JIT | Substantially Equivalent | |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | PDJ | Substantially Equivalent | |
| K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI | MRG | Substantially Equivalent | |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | LPS | Substantially Equivalent | |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | CKG | Substantially Equivalent | |
| K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET | JIT | Substantially Equivalent | |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | NDY | Substantially Equivalent | |
| K100304 | ST AIA PACK HBA1C | LCP | Substantially Equivalent | |
| K091332 | AIA-PACK RBC FOLATE | CGN | Substantially Equivalent | |
| K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | LCP | Substantially Equivalent | |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | CEW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005529799 | 3005529799 | TOSOH BIOSCIENCE, INC. | 3600 Gantz Rd, Grove City, OH 43123 US | 2026 | and 47 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CGNAcid, Folic, Radioimmunoassay
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- LCPAssay, Glycosylated Hemoglobin
- JISCalibrator, Primary
- JITCalibrator, Secondary
- GIFDiluent, Blood Cell
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- DBFFerritin, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- JFTFluorometric, Cortisol
- PPMGeneral Purpose Reagent
- PDJHemoglobin A1c Test System
- DGCIge, Antigen, Antiserum, Control
- MMIImmunoassay Method, Troponin Subunit
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- DDRMyoglobin, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- DHXSystem, Test, Carcinoembryonic Antigen
- MOISystem, Test, Immunological, Antigen, Tumor
- JZOSystem, Test, Thyroid Autoantibody
- MRGSystem, Test, Vitamin D
- NDYTest, Cystatin C
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- MZFTest, Hiv Detection
- NBCTest, Natriuretic Peptide
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- LPSUrinary Homocystine (Nonquantitative) Test System
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
Showing 25 of 84| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2746-2026 | 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 | The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures. | Class II | Open, Classified | |
| Z-2968-2020 | 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 | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%. | Class II | Terminated | |
| Z-2967-2020 | 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 VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%. | Class II | Terminated | |
| Z-2423-2020 | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. | Class II | Terminated | |
| Z-1420-2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable. | Class II | Terminated | |
| Z-0745-2020 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 | The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle. In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898. | Class III | Terminated | |
| Z-0676-2019 | 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 disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome. | Class II | Terminated | ||
| Z-0675-2019 | 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 hyperhomocysteinemia or homocysteinuria. | Class II | Terminated | ||
| Z-0674-2019 | 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 excess or deficiency of this androgen. | Class II | Terminated | ||
| Z-0673-2019 | 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. | Class II | Terminated | ||
| Z-0672-2019 | 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 analyzers. | Class II | Terminated | ||
| Z-0671-2019 | 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 AIA System analyzers. | Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays | Class II | Terminated | |
| Z-0509-2019 | 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 immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series. | Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received five (5) complaints related to this issue with no serious injuries reported. | Class II | Terminated | |
| Z-0601-2019 | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported. | Class III | Terminated | |
| Z-0469-2019 | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported. | Class II | Terminated | |
| Z-0485-2019 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result. | Class II | Terminated | |
| Z-0475-2019 | 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 antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series. | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue. | Class II | Terminated | |
| Z-0600-2019 | 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 immunoassay. | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue. | Class II | Terminated | |
| Z-0599-2019 | 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 immunoenzymetric immunoassay. | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue. | Class II | Terminated | |
| Z-0559-2019 | 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. | The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively. | Class II | Terminated | |
| Z-3244-2018 | 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 developing diabetes. | Analyzers were distributed with software which lacks a 510K | Class II | Terminated | |
| Z-2745-2018 | 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 hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. | HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE. | Class II | Terminated | |
| Z-2827-2018 | 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 section on assay controls in the analyte application manual. | Distribution of unapproved product labeling | Class III | Terminated | |
| Z-2099-2018 | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. | Class II | Terminated | |
| Z-2098-2018 | ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain