Tosoh Bioscience Inc recalls
Every recall we track for Tosoh Bioscience Inc — 66 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Tosoh Bioscience Inc peaked in 2018 (58); 66 since 2017.
All FDA recall records for Tosoh Bioscience Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 2 | 0 | 3 |
| 2018 | 0 | 3 | 50 | 5 | 58 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 4 | 0 | 4 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Tosoh Bioscience Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Tosoh Bioscience Inc recalls
20 shown- Lower riskMedical device
Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum
Tosoh recalls specific testosterone test kits that may give false high or low results, causing unnecessary treatments or delayed diagnoses. Affected units include certain lot numbers on specific analyzers.
TosohJun 12, 2026 - Lower riskMedical device
Tosoh Bioscience Inc recalls Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number:
Tosoh Bioscience recalls specific lots of BHCG pregnancy test sets due to potential 20% lower HCG concentration readings. Affected units may give inaccurate pregnancy results. Contact for replacement.
Tosoh BioscienceAug 7, 2020 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Tosoh Bioscience recalls AIA-900 Analyzers with serial numbers 10030810 and higher due to a substrate monitoring system that may not detect empty bottles, leading to incorrect test results.
Tosoh BioscienceMay 22, 2020 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Tosoh Bioscience recalls AIA-360 Automated Immunoassay Analyzers with software issue causing display freezes when touched during command execution, leading to aborted runs and unretrievable results.
Tosoh BioscienceJan 10, 2020 - UnratedMedical device
Tosoh Bioscience Inc recalls ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative
Tosoh Bioscience recalls ST AIA-PACK ACTH diagnostic kits for accurate ACTH measurement. This in vitro diagnostic product is used for adrenal gland disorders. All lots are affected.
Tosoh BioscienceNov 30, 2018 - Use cautionMedical device
Tosoh Bioscience Inc recalls AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of
Tosoh recalls AIA-900 analyzers with potential timing belt misalignment causing motor damage. Five complaints reported with no serious injuries. Affected units include specific serial numbers.
Tosoh BioscienceOct 5, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-900 Analyzer, Product code 022930, 022930R
Tosoh recalls AIA-900 Analyzers with potential pickup arm motor issues that may cause testing delays. No serious injuries reported in 51 complaints.
TosohOct 5, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory
Tosoh recalls Hemoglobin A1c Control (Lot 7055) due to potential degradation affecting lab test accuracy. This may cause delays in patient results. No serious injuries reported.
Tosoh BioscienceOct 5, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls Tosoh AIA-900 immunoassay Analyzer
Tosoh recalls AIA-900 immunoassay analyzers due to software issue causing potential test delays. Affected units may need software update to prevent inaccurate results.
TosohSep 28, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three
Tosoh Bioscience recalls AIA-2000LA and AIA-2000ST analyzers with serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511. Incomplete washing may cause false test results for some blood tests.
Tosoh BioscienceSep 28, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable
Tosoh recalls AIA-2000 and AIA-900 analyzers with potential incubator slippage causing testing delays. No injuries reported. Check product codes 022100, 022100R, 022101, 022101R.
Tosoh BioscienceSep 28, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro
Tosoh recalls AIA-360 analyzers due to labeling changes affecting maintenance procedures. Failure to follow new requirements may cause corrosion, contamination, or system failure. Affected units have product code 019945/019945R.
TosohAug 23, 2018 - UnratedMedical device
Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of %
Tosoh recalls G8 HPLC analyzers with software missing a 510K clearance for hemoglobin A1c testing in diabetes diagnosis. Affected units have specific serial numbers listed.
Tosoh Biosc: IncJul 13, 2018 - Use cautionMedical device
Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated
Tosoh recalls HLC-723G8-ST and HLC-723G8-LA analyzers with software version 5.23. HbAE can cause invalid diabetes test results if Flag 43 isn't enabled. Users should check software settings to avoid inaccurate readings.
TosohJun 6, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals
Tosoh Bioscience recalls AIA Analyte Application Manual CD (part 997027) due to unapproved labeling. This CD contains manuals for 47 analyte reagent packs used with their AIA analyzers. Consumers should check if they own this CD and contact Tosoh for details.
Tosoh Biosc: AIA Analyte Application ManualJun 5, 2018 - Use cautionMedical device
Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for
Tosoh recalls HbA1c Control kits for inaccurate diabetes test results. Affected kits may give wrong blood sugar readings, causing health risks. Stop using immediately.
TosohMar 5, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Tosoh Bioscience recalls ST-AIA PACK Testosterone (Part 025204) due to potential false test results. Affected units may cause inaccurate hormone measurements.
Tosoh BioscienceMar 5, 2018 - Lower riskMedical device
Tosoh Bioscience Inc recalls ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Tosoh Bioscience recalls ST AIA-PACK PROG III assay (part 025240) due to false high progesterone readings from DHEA-S cross-reactivity. Affected units may give inaccurate test results.
Tosoh Biosc: IncFeb 13, 2018 - Use cautionMedical device
Tosoh Bioscience Inc recalls AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich
Tosoh recalls AIA-900 analyzers with potential harness wear causing system errors. Affected units may show error code 4093 and stop functioning. No injuries reported.
TosohSep 28, 2017 - Lower riskMedical device
Tosoh Bioscience Inc recalls Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated
Tosoh recalls AIA-900 analyzers with serial numbers 10000103 to 11147003 due to potential photo interrupter failure from aging. Affected users should contact Tosoh for details.
TosohJun 11, 2017
Tosoh Bioscience Inc recall questions
How many recalls has Tosoh Bioscience Inc had?
66 recalls from Tosoh Bioscience Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Tosoh Bioscience Inc recall?
Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum, dated Jun 12, 2026. Every Tosoh Bioscience Inc recall is listed on this page, newest first.
What should I do if I have a recalled Tosoh Bioscience Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Tosoh Bioscience Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.