Tosoh Bioscience Inc
Medical device manufacturer in Grove City, OH.
20510(k) clearances
1PMA approvals
77recalls
Device types
- JIT Calibrator, Secondary 5
- PDJ Hemoglobin A1c Test System 3
- LCP Assay, Glycosylated Hemoglobin 2
- MRG System, Test, Vitamin D 2
- CEW Radioimmunoassay, Parathyroid Hormone 1
- CGN Acid, Folic, Radioimmunoassay 1
- NDY Test, Cystatin C 1
- CKG Radioimmunoassay, Acth 1
- LPS Urinary Homocystine (Nonquantitative) Test… 1
- JJX Single (Specified) Analyte Controls… 1
- CDZ Radioimmunoassay, Testosterones And… 1
- NBC Test, Natriuretic Peptide 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | 10/03/2025SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | 11/08/2021SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | 08/05/2021SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | 12/18/2015SE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…MRG · Traditional | 10/26/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | 07/02/2015SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | 12/16/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | 12/03/2014SE |
| K140648 | ST Aia-Pack C-Peptide II Calibrator SetJIT · Abbreviated | 04/10/2014SE |
| K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8PDJ · Traditional | 01/23/2014SE |
| K123131 | ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator Set, Aia-Pack 25-OH…MRG · Traditional | 02/08/2013SE |
| K121533 | ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…LPS · Traditional | 06/15/2012SE |
| K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321CKG · Traditional | 12/01/2011SE |
| K111762 | ST Aia-Pack Dhea-S Calibrator SetJIT · Abbreviated | 08/05/2011SE |
| K093960 | ST Aia-Pack Cystatin C, Model 025217NDY · Traditional | 09/14/2010SE |
| K100304 | ST Aia Pack HBA1CLCP · Traditional | 08/27/2010SE |
| K091332 | Aia-Pack RBC FolateCGN · Traditional | 10/02/2009SE |
| K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8LCP · Traditional | 09/16/2008SE |
| K063605 | ST Aia-Pack Intact PTH AssayCEW · Traditional | 06/21/2007SE |
PMA approvals
- P910065 Aia-Pack Psa · 07/07/1993 · 9 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2746-2026 Class II | ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement…The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the… | 06/12/2026Open, Classified |
| Z-2968-2020 Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for…Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting… | 08/07/2020Terminated |
| Z-2967-2020 Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number…Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting… | 08/07/2020Terminated |
| Z-2423-2020 Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue… | 05/22/2020Terminated |
| Z-1420-2020 Class II | AIA-360 Automated Immunoassay Analyzer, Product Code 019945A display screen software issue on the analyzer causes the display to freeze when display screen is touched… | 01/10/2020Terminated |
| Z-0676-2019 Class II | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC… | 11/30/2018Terminated |
| Z-0675-2019 Class II | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… | 11/30/2018Terminated |
| Z-0674-2019 Class II | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… | 11/30/2018Terminated |
| Z-0673-2019 Class II | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE… | 11/30/2018Terminated |
| Z-0672-2019 Class II | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative… | 11/30/2018Terminated |
| Z-0671-2019 Class II | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the…Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays | 11/30/2018Terminated |
| Z-0601-2019 Class III | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor…Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days… | 10/05/2018Terminated |
| Z-0509-2019 Class II | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The…Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive… | 10/05/2018Terminated |
| Z-0469-2019 Class II | AIA-900 Analyzer, Product code 022930, 022930RTosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the… | 10/05/2018Terminated |
| Z-0600-2019 Class II | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer…Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could… | 09/28/2018Terminated |
| Z-0599-2019 Class II | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer…Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could… | 09/28/2018Terminated |
| Z-0485-2019 Class II | Tosoh AIA-900 immunoassay AnalyzerA software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be… | 09/28/2018Terminated |
| Z-0475-2019 Class II | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is…There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended… | 09/28/2018Terminated |
| Z-0559-2019 Class II | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay…The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes… | 08/23/2018Terminated |
| Z-3244-2018 Class II | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the…Analyzers were distributed with software which lacks a 510K | 07/13/2018Terminated |
| Z-2745-2018 Class II | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product…HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers… | 06/06/2018Terminated |
| Z-2827-2018 Class III | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains…Distribution of unapproved product labeling | 06/05/2018Terminated |
| Z-2099-2018 Class II | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2098-2018 Class II | ST-AIA PACK BMG; Part Number:025259 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2097-2018 Class II | ST-AIA PACK IGE II; Part Number: 025295 Assay, AllergyAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2096-2018 Class II | ST-AIA PACK Fer; Part Number: 025253 Assay, AnemiaAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2095-2018 Class II | ST-AIA PACK HGH; Part Number: 025266 Assay, MetabolicAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2094-2018 Class II | ST-AIA PACK Cort; Part Number: 025287 Assay, MetabolicAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2093-2018 Class II | ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2092-2018 Class II | ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2091-2018 Class II | ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2090-2018 Class II | ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2089-2018 Class II | ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2088-2018 Class II | ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2087-2018 Class II | ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2086-2018 Class II | ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2085-2018 Class II | ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2084-2018 Class II | ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2083-2018 Class II | ST-AIA PACK HCG; Part Number: 025261 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2082-2018 Class II | ST-AIA PACK TU; Part Number: 025270 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2081-2018 Class II | ST-AIA PACK FT4; Part Number: 025268 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2080-2018 Class II | ST-AIA PACK FT3; Part Number: 025286 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2079-2018 Class II | ST-AIA PACK T4; Part Number: 025258 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2078-2018 Class II | ST-AIA PACK TT3; Part Number: 025282 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2077-2018 Class II | AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, ThyroidAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2076-2018 Class II | ST-AIA PACK IRI; Part Number: 025260 Assay, DiabetesAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2075-2018 Class II | ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, DiabetesAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2074-2018 Class II | ST-AIA PACK C-Peptide; Part Number: 025284 Assay, DiabetesAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2073-2018 Class II | ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2072-2018 Class II | ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2071-2018 Class II | ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2070-2018 Class II | ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2069-2018 Class II | ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2068-2018 Class II | ST-AIA PACK PAP; Part Number: 025262 Assay, ProstateAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2067-2018 Class II | ST-AIA PACK PA; Part Number: 025263 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2066-2018 Class II | ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-2065-2018 Class II | ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | 03/05/2018Terminated |
| Z-1812-2018 Class II | Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-1811-2018 Class II | Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-1810-2018 Class II | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-1809-2018 Class II | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-0826-2018 Class II | ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due… | 02/13/2018Terminated |
| Z-0825-2018 Class II | ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due… | 02/13/2018Terminated |
| Z-0602-2019 Class II | AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an…The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing… | 09/28/2017Terminated |
| Z-0492-2018 Class II | TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code 022932.…This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential… | 06/11/2017Terminated |
| Z-0491-2018 Class II | TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product…This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential… | 06/11/2017Terminated |
| Z-0613-2019 Class II | AIA-360 Analyzer is capable of performing two methods of immunoassay: an…The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home… | 03/22/2017Terminated |
| Z-2169-2017 Class III | AIA-PACK TgAb CONTROL SETThe label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL)… | 02/08/2017Terminated |
| Z-2168-2017 Class III | AIA-PACK TPOAb CONTROL SETThe label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL)… | 02/08/2017Terminated |
| Z-1225-2017 Class II | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.The device defect associated with this recall may result in HbA1c values with a negative bias in patients… | 11/07/2016Terminated |
| Z-2282-2016 Class III | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one…Instructions For Use had incorrect lot number and calibrator values | 06/07/2016Terminated |
| Z-2066-2015 Class III | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin…The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015.… | 02/10/2015Terminated |
| Z-1187-2021 Class II | Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO…Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the… | 02/23/2012Terminated |
| Z-3030-2011 | Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh…The value after reconstitution appeared to be lower than the assigned value on the label. The measured value… | 05/25/2011Terminated |
| Z-1075-2013 Class III | G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal…The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid… | 08/18/2010Terminated |
| Z-0007-2008 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of…Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was… | 06/22/2007Terminated |
| Z-0082-2007 | TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The…Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate… | 09/01/2006Terminated |