Tosoh Bioscience recalls
Tosoh Bioscience appears in 74 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 74 |
|---|---|
| Published | 2013-04-17 to 2026-07-22 |
| By agency | FDA Device (74) |
| By classification | Class II (67), Class III (7) |
| By status | terminated (73), ongoing (1) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
FDA Device · Class II · 2026-07-22 · Tosoh Bioscience
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 resu… - Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of ant…
FDA Device · Class II · 2021-03-17 · Tosoh Bioscience
Reason: Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable. - Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended…
FDA Device · Class II · 2020-09-23 · Tosoh Bioscience
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%. - Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BH…
FDA Device · Class II · 2020-09-23 · Tosoh Bioscience
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%. - AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
FDA Device · Class II · 2020-07-01 · Tosoh Bioscience
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. - AIA-360 Automated Immunoassay Analyzer, Product Code 019945
FDA Device · Class II · 2020-03-11 · Tosoh Bioscience
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 ru… - AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA S…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodot…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adren…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human seru…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience
Reason: Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays - ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive bin…
FDA Device · Class II · 2018-12-26 · Tosoh Bioscience
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-3… - Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for H…
FDA Device · Class III · 2018-12-19 · Tosoh Bioscience
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 v… - AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience
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… - AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience
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 ad… - AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoa…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience
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 ad… - AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide te…
FDA Device · Class II · 2018-12-12 · Tosoh Bioscience
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 Bioscien… - AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of i…
FDA Device · Class II · 2018-12-05 · Tosoh Bioscience
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… - Tosoh AIA-900 immunoassay Analyzer
FDA Device · Class II · 2018-11-28 · Tosoh Bioscience
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… - AIA-2000 Analyzer, Model Nos
FDA Device · Class II · 2018-11-28 · Tosoh Bioscience
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 t… - AIA-900 Analyzer, Product code 022930, 022930R
FDA Device · Class II · 2018-11-21 · Tosoh Bioscience
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… - G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole bl…
FDA Device · Class II · 2018-10-03 · Tosoh Bioscience
Reason: Analyzers were distributed with software which lacks a 510K - Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent…
FDA Device · Class III · 2018-08-22 · Tosoh Bioscience
Reason: Distribution of unapproved product labeling - G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560
FDA Device · Class II · 2018-08-22 · Tosoh Bioscience
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 r… - ST-AIA PACK AFP
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK 27.29
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK ¿HCG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK FT3
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK CA 19-9
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - AIA-PACK TSH 3rd Generation
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Cystatin C
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA DHEA-S
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Myoglobin
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK TT3
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Prolactin
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK BMG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK T4
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK PA
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Cort
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK hsE2
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK IRI
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK C-Peptide II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Prog II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK C-Peptide
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK PAP
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK IGE II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK HGH
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK cTnI 2nd Gen
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. - ST-AIA PACK Testosterone
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience
Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.