Recall Register

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Tosoh Bioscience Inc

FDA recalling firm · 27 enforcement events · 74 product records · 2010–2026 · OH, CA

Tosoh Bioscience Inc has 27 FDA enforcement events on this register (74 product records) between 2010 and 2026: 27 device; the busiest year was 2018 with 14.

0% of its events are Class I; the most common class is Class II (21). 1 event is listed as ongoing; the recalling firm's address is in OH and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Device27
Class II21
Class III6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

10
12
14
16
18
20
22
24
26
Enforcement events for Tosoh Bioscience Inc by year initiated.

Questions and answers

How many FDA recalls has Tosoh Bioscience Inc had?

27 enforcement events (74 product records) on this register, 2010–2026: 27 device.

Are any Tosoh Bioscience Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Tosoh Bioscience Inc recalls?

21 Class II, 6 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.