Recall Register

Tosoh Bioscience Inc: FDA recalls

FDA enforcement events from 2010 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Tosoh Bioscience Inc as the recalling firm in 27 events. The events have 74 product records. The recalls started from 2010 to 2026. All the events are device recalls. By FDA enforcement events, Tosoh Bioscience Inc is number 128 of 1,628 firms that have a page. Events that Tosoh Bioscience Inc started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class III is 22.2% of its events and 8.6% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

27 events, newest first.

FDA enforcement events of Tosoh Bioscience Inc
InitiatedProduct (first record)TypeClassRecordsStatus
12 Jun 2026ST 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 0025204DeviceClass II1Ongoing
7 Aug 2020Tosoh 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 assayDeviceClass II2Terminated
22 May 2020AIA-900 Analyzer, Part no. 022930, UDI 04560189283992DeviceClass II1Terminated
10 Jan 2020AIA-360 Automated Immunoassay Analyzer, Product Code 019945DeviceClass II1Terminated
30 Nov 2018AIA-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.DeviceClass II6Terminated
5 Oct 2018Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.DeviceClass III1Terminated
5 Oct 2018AIA-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…DeviceClass II1Terminated
5 Oct 2018AIA-900 Analyzer, Product code 022930, 022930RDeviceClass II1Terminated
28 Sep 2018AIA-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…DeviceClass II1Terminated
28 Sep 2018Tosoh AIA-900 immunoassay AnalyzerDeviceClass II1Terminated
28 Sep 2018AIA-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.DeviceClass II2Terminated
23 Aug 2018AIA-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.DeviceClass II1Terminated
13 Jul 2018G8 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.DeviceClass II1Terminated
6 Jun 2018G8 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.…DeviceClass II1Terminated
5 Jun 2018Tosoh 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…DeviceClass III1Terminated
5 Mar 2018ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor MarkerDeviceClass II35Terminated
5 Mar 2018Tosoh 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 on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.DeviceClass II4Terminated
13 Feb 2018ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239DeviceClass II2Terminated
28 Sep 2017AIA-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.DeviceClass II1Terminated
11 Jun 2017Tosoh 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 variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.DeviceClass II2Terminated
22 Mar 2017AIA-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 immunoreaction test cup from the AIA-PACK…DeviceClass II1Terminated
8 Feb 2017AIA-PACK TPOAb CONTROL SETDeviceClass III2Terminated
7 Nov 2016Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.DeviceClass II1Terminated
7 Jun 2016Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.DeviceClass III1Terminated
10 Feb 2015G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.DeviceClass III1Terminated
23 Feb 2012Thyroglobulin 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 diagnosis of autoimmune thyroid disorders,…DeviceClass II1Terminated
18 Aug 2010G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.DeviceClass III1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Tosoh Bioscience Inc: events for each product type
TypeEvents
Device27
Tosoh Bioscience Inc: events in each class
ClassEvents
Class II21
Class III6
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Tosoh Bioscience Inc, by the year that the recall started. The largest year is 2018, with 14 events.

Official channels

Cite this page

Recall Register. Tosoh Bioscience Inc: FDA recalls. https://recallregister.com/firm/tosoh-bioscience-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
OH, CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Tosoh Bioscience Inc have?
Class II: 21 events. Class III: 6 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Tosoh Bioscience Inc?
FDA event 99210, which the firm started on 12 Jun 2026. The first product in the record is: 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
How many FDA recalls of Tosoh Bioscience Inc have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.