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Tosoh Bioscience Recalls
74 recalls on record · April 17, 2013 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
June 13, 2018Medical DevicesFDA
Tosoh Bioscience Inc recalls ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Hazard: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.