Grove City, OH, United States
Tosoh Bioscience Inc recalls
22 recalls recorded since 2018, most recently on 12 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls22
Ongoing (FDA)1
Terminated or completed21
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 June 2026
- Reason
- 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.
- Distribution
- Global Distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 7 August 2020
- Terminated
- 21 June 2021
- Reason
- 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%.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2968-2020, Z-2967-2020
- 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 calibr
- 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
Terminated Class II Medical devices
- Recall started
- 22 May 2020
- Terminated
- 29 August 2024
- Reason
- 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.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2423-2020
- AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Terminated Class II Medical devices
- Recall started
- 10 January 2020
- Terminated
- 10 September 2020
- Reason
- 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.
- Distribution
- Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1420-2020
- AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Terminated Class II Medical devices
- Recall started
- 30 November 2018
- Terminated
- 14 January 2021
- Reason
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0676-2019, Z-0672-2019, Z-0675-2019, Z-0674-2019, Z-0673-2019, Z-0671-2019
- 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 use
- 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.
- 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
- 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 a
- 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
- 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.
Terminated Class III Medical devices
- Recall started
- 5 October 2018
- Terminated
- 16 June 2020
- Reason
- 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.
- Distribution
- Distributed nationwide. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 5 October 2018
- Terminated
- 10 November 2020
- Reason
- 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.
- Distribution
- Distributed nationwide. Foreign distribution to Canada and Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0469-2019
- AIA-900 Analyzer, Product code 022930, 022930R
Terminated Class II Medical devices
- Recall started
- 5 October 2018
- Terminated
- 27 August 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, MD, NV, NY, SC, and TX. and Foreign distribution to Cayman Islands, Chile, Columbia, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Puerto Rico, Uruguay, and Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 28 September 2018
- Terminated
- 3 September 2020
- Reason
- 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.
- Distribution
- US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0599-2019, Z-0600-2019
- 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,
- 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 bindin
Terminated Class II Medical devices
- Recall started
- 28 September 2018
- Terminated
- 29 May 2020
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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) i
Terminated Class II Medical devices
- Recall started
- 28 September 2018
- Terminated
- 8 July 2020
- Reason
- 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.
- Distribution
- Distributed to accounts in GA and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0485-2019
- Tosoh AIA-900 immunoassay Analyzer
Terminated Class II Medical devices
- Recall started
- 23 August 2018
- Terminated
- 20 October 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 13 July 2018
- Terminated
- 8 July 2020
- Reason
- Analyzers were distributed with software which lacks a 510K
- Distribution
- US Nationwide Distribution in states of - CA, OK, VA 7 WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 6 June 2018
- Terminated
- 9 February 2021
- Reason
- 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.
- Distribution
- Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 measuremen
Terminated Class III Medical devices
- Recall started
- 5 June 2018
- Terminated
- 3 April 2020
- Reason
- Distribution of unapproved product labeling
- Distribution
- US Distribution to states of: FL, MA, MT, OK, OR and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 analyzer
Terminated Class II Medical devices
- Recall started
- 5 March 2018
- Terminated
- 31 August 2020
- Reason
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2093-2018, Z-2094-2018, Z-2087-2018, Z-2069-2018, Z-2096-2018, Z-2083-2018, Z-2097-2018, Z-2086-2018, Z-2067-2018, Z-2079-2018, Z-2066-2018, Z-2091-2018 and 23 more
- 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
- and 27 more product lines
Terminated Class II Medical devices
- Recall started
- 5 March 2018
- Terminated
- 16 June 2020
- Reason
- The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- Distribution
- USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1811-2018, Z-1809-2018, Z-1810-2018, Z-1812-2018
- Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
- Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood o
- Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
- Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c as
Terminated Class II Medical devices
- Recall started
- 13 February 2018
- Terminated
- 29 October 2020
- Reason
- Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
- Distribution
- Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0826-2018, Z-0825-2018
- ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
- ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
Terminated Class II Medical devices
- Recall started
- 28 September 2017
- Terminated
- 8 December 2020
- Reason
- The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness 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 is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
- Distribution
- Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0602-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 11 June 2017
- Terminated
- 31 December 2019
- Reason
- This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
- Distribution
- Worldwide Distribution - U.S. Nationwide - Latin America
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0491-2018, Z-0492-2018
- Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a varie
- Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
Terminated Class II Medical devices
- Recall started
- 22 March 2017
- Terminated
- 9 December 2020
- Reason
- The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 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 three (3) complaints related to this issue with no serious injuries reported.
- Distribution
- Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0613-2019
- 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 patien
Terminated Class II Medical devices
- Recall started
- 23 February 2012
- Terminated
- 8 July 2021
- Reason
- Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1187-2021
- 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 an
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.