Tosoh Bioscience Inc
Complete recall history across all FDA and CPSC categories — 68 total recalls
Tosoh Bioscience Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (68)
FDA medical device enforcement actions by Tosoh Bioscience Inc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 7, 2020 | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG P... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Veri... | Class II |
| Aug 7, 2020 | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Dia... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Veri... | Class II |
| May 22, 2020 | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an emp... | Class II |
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze ... | Class II |
| Nov 30, 2018 | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for t... | Potential for fluorescein interference to cause inaccurately elevated results... | Class II |
| Nov 30, 2018 | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOS... | Class II | |
| Nov 30, 2018 | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | |
| Nov 30, 2018 | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | |
| Nov 30, 2018 | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu... | Class II | |
| Nov 30, 2018 | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO... | Class II | |
| Oct 5, 2018 | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Produ... | Tosoh Bioscience has become aware of a potential issue with the axis base of ... | Class II |
| Oct 5, 2018 | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience has become aware of a potential issue with the pickup arm an... | Class II |
| Oct 5, 2018 | Hemoglobin A1c Control, Part no. 220232 for use as quality control material t... | Tosoh Bioscience has become aware of potential degradation of HbA1c control l... | Class III |
| Sep 28, 2018 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3r... | Class II |
| Sep 28, 2018 | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AI... | There is a possibility that the liquid suction pump on some AIA-2000 analyzer... | Class II |
| Sep 28, 2018 | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AI... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and A... | Class II |
| Sep 28, 2018 | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and A... | Class II |
| Aug 23, 2018 | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... | The firm has implemented new product labeling changes for the Tosoh AIA-360 A... | Class II |
| Jul 13, 2018 | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... | Analyzers were distributed with software which lacks a 510K | Class II |
| Jun 6, 2018 | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... | HbAE is known to interfere with the HbA1c assay on the current version of sof... | Class II |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III |
| Mar 5, 2018 | ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, P... | The assay can potentially generate erroneously elevated or erroneously decrea... | Class II |
| Mar 5, 2018 | ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The produc... | The assay can potentially generate erroneously elevated or erroneously decrea... | Class II |
| Mar 5, 2018 | ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is desig... | The assay can potentially generate erroneously elevated or erroneously decrea... | Class II |
| Mar 5, 2018 | ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
| Mar 5, 2018 | ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potential... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.