Data / Medical devices / United States / Tosoh Bioscience, Inc.

Tosoh Bioscience, Inc.: FDA-registered device maker in Grove City, OH, United States, 53 510(k) clearances and 1 PMA approval

Name: Tosoh Bioscience, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tosoh Bioscience, Inc. is registered with the FDA (registration 3005529799) in Grove City, OH, United States. It lists 57 device types. The FDA files 53 510(k) clearances and 1 PMA approval under its listings, the newest dated October 3, 2025. 30 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005529799
Address: 3600 Gantz Rd, Grove City, OH, United States, 43123
Owner or operator: TOSOH BIOSCIENCE (8031673)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: April 4, 1994
Registered through: 2026
Brand names listed: AIA-PACK FOLATE Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, AIA-PACK 27.29 Calibrator Set, AIA-PACK 27.29 Sample Diluting Solution, AIA-PACK ?HCG Calibration Verification Test Set, AIA-PACK ?HCG Calibrator Set, AIA-PACK ?HCG Sample Diluting Solution, AIA-PACK ACTH Control Set and more

Devices it lists

Device	Product code	Class	Role	Source
Acid Phosphatase (Prostatic), Tartrate Inhibited	JFH	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Acid, Folic, Radioimmunoassay	CGN	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Calibrator, Primary	JIS	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Fluorometric, Cortisol	JFT	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
General Purpose Reagent	PPM	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Acth	CKG	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Test, Cystatin C	NDY	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 3, 2025	K250073	Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01	PDJ	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
August 24, 2020	K192380	ST AIA-PACK BNP	NBC	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
February 17, 2016	K160113	ST AIA-PACK hsE2 Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 18, 2015	K153417	ST AIA-PACK PROG III Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
October 26, 2015	K150270	ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set	MRG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
July 2, 2015	K143075	ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set	CDZ	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 16, 2014	K143296	AIA-PACK C-Peptide Control Set	JJX	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 3, 2014	K143144	ST AIA-PACK PROG II Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
April 10, 2014	K140648	ST AIA-PACK C-PEPTIDE II CALIBRATOR SET	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
January 23, 2014	K131580	AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8	PDJ	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
February 8, 2013	K123131	ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI	MRG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
June 15, 2012	K121533	ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET	LPS	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 1, 2011	K111335	ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321	CKG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
August 5, 2011	K111762	ST AIA-PACK DHEA-S CALIBRATOR SET	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
September 14, 2010	K093960	ST AIA-PACK CYSTATIN C, MODEL 025217	NDY	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
October 2, 2009	K091332	AIA-PACK RBC FOLATE	CGN	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
September 16, 2008	K071132	G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8	LCP	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
June 21, 2007	K063605	ST AIA-PACK INTACT PTH ASSAY	CEW	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 23, 2002	K023240	ST AIA-PACK CA 19-9	NIG	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
December 18, 2002	K023893	ST AIA-PACK CEA ENZYME IMMUNOASSAY	DHX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 17, 2002	K023894	ST AIA-PACK AFP ENZYME IMMUNOASSAY	LOJ	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 17, 2002	K023091	ST AIA-PACK TESTOSTERONE ASSAY	CDZ	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 6, 2002	K023891	ST AIA-PACK CA 125 ENZYME IMMUNOASSAY	LTK	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 14, 2001	K012820	AIA-PACK CTNI 2ND-GEN ASSAY	MMI	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 16, 2001	K010796	AIA-PACK BRCA, ST AIA PACK BRCA	MOI	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 10, 1999	K992365	AIA-PACK FOLATE ASSAY	CGN	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
May 11, 1999	K991252	AIA-PACK FT3 ASSAY	CDP	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 8, 1998	K981522	AIA-PACK TGAB ASSAY	JZO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 8, 1998	K981521	AIA-PACK TPOAB ASSAY	JZO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
May 28, 1998	K981012	AIA-PACK MYOGLOBIN ASSAY	DDR	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 3, 1997	K972697	AIA-PACK IGE II ASSAY	DGC	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 29, 1997	K972586	AIA-PACK TSH 3RD-GEN ASSAY	JLW	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
June 27, 1997	K971103	AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM	KHO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
January 13, 1997	K964348	AIA-PACK B12 ASSAY	CDD	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 15, 1995	K954591	AIA-PACK CORT ASSAY	JFT	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
July 14, 1994	K936229	AIA-PACK TT3 ASSAY	CDP	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
September 21, 1993	K932178	AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
March 18, 1993	K924857	AIA-PACK CEA CALIBRATION VERIFICATION TEST SET	DHX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
March 4, 1993	K924860	AIA-PACK AFP CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
January 11, 1993	K924856	AIA-PACK PRL CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 28, 1992	K924853	AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 15, 1992	K924858	AIA-PACK FER CALIBRATION VERIFICATION TEST SET	DBF	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
November 16, 1992	K924863	AIA-PACK FSH CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
November 16, 1992	K924854	AIA-PACK PAP CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
September 30, 1991	K913663	AIA-PACK T-U	KHQ	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
September 27, 1991	K913298	AIA-PACK CK-MB	JHX	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
September 10, 1991	K913493	AIA-PACK FT4	CEC	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
March 9, 1990	K896982	AIA-PACK T4	KLI	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
February 26, 1990	K900440	AIA-PACK BMG	JZG	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
April 8, 1987	K870521	TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY	JHI	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
January 5, 1987	K864945	TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY	JFH	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
November 21, 1986	K863861	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA	JHI	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
October 8, 1986	K863345	TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY	DBF	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 7, 1993	P910065	AIA-PACK PSA	MTF	9	June 18, 2019	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 12, 2026	99210	Class II	Ongoing	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	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 diagnos	accessdata.fda.gov
August 7, 2020	86218	Class II	Terminated	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 assa	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%.	accessdata.fda.gov
May 22, 2020	85753	Class II	Terminated	AIA-900 Analyzer, Part no. 022930, UDI 04560189283992	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.	accessdata.fda.gov
January 10, 2020	84787	Class II	Terminated	AIA-360 Automated Immunoassay Analyzer, Product Code 019945	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.	accessdata.fda.gov
November 15, 2019	84299	Class III	Terminated	AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706	The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle. In	accessdata.fda.gov
November 30, 2018	81597	Class II	Terminated	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.	Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays	accessdata.fda.gov
October 5, 2018	81212	Class II	Terminated	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 bin	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	accessdata.fda.gov
October 5, 2018	81188	Class III	Terminated	Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.	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 o	accessdata.fda.gov
October 5, 2018	81187	Class II	Terminated	AIA-900 Analyzer, Product code 022930, 022930R	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)	accessdata.fda.gov
September 28, 2018	81219	Class II	Terminated	Tosoh AIA-900 immunoassay Analyzer	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 pat	accessdata.fda.gov
September 28, 2018	81194	Class II	Terminated	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) im	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	accessdata.fda.gov
September 28, 2018	81190	Class II	Terminated	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, a co	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 t	accessdata.fda.gov
August 23, 2018	81054	Class II	Terminated	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.	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 provi	accessdata.fda.gov
July 13, 2018	80585	Class II	Terminated	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 and	Analyzers were distributed with software which lacks a 510K	accessdata.fda.gov
June 6, 2018	80257	Class II	Terminated	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 measurement of	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.	accessdata.fda.gov
June 5, 2018	80482	Class III	Terminated	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 analyzers. E	Distribution of unapproved product labeling	accessdata.fda.gov
March 5, 2018	79813	Class II	Terminated	ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker	Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.	accessdata.fda.gov
March 5, 2018	79708	Class II	Terminated	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 on T	The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.	accessdata.fda.gov
February 13, 2018	79176	Class II	Terminated	ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239	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.	accessdata.fda.gov
September 28, 2017	81172	Class II	Terminated	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.	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	accessdata.fda.gov
June 11, 2017	78776	Class II	Terminated	TosohAutomated 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	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.	accessdata.fda.gov
March 22, 2017	81170	Class II	Terminated	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	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 functi	accessdata.fda.gov
December 22, 2016	76173	Class II	Terminated	Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repositor	Power outages causes reporting software to shutdown.	accessdata.fda.gov
May 15, 2013	65576	Class II	Terminated	AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyz	Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.	accessdata.fda.gov
February 23, 2012	76372	Class II	Terminated	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 ana	Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.	accessdata.fda.gov
May 25, 2011	59488	Not yet classified	Terminated	Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the	The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.	accessdata.fda.gov
August 18, 2010	56584	Class III	Terminated	G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.	The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.	accessdata.fda.gov
June 22, 2007	38494	Not yet classified	Terminated	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.	Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.	accessdata.fda.gov
September 1, 2006	36506	Not yet classified	Terminated	TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.	Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument	accessdata.fda.gov
January 26, 2006	34547	Not yet classified	Terminated	TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray	The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.	accessdata.fda.gov

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Updated July 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.