The Recall Desk

Manufacturer

Tosoh Bioscience, Inc.

74 recalls in our database name Tosoh Bioscience, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
74
Critical
0
Severe
0
Most recent
2026-07-22

Of the 74 recalls from Tosoh Bioscience, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 74

  • HighFDA (Devices)·Z-2088-2018·2018-06-13

    Tosoh Estradiol Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Estradiol assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2018·2018-06-13

    Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa can cause inaccurate test results.

    Product
    ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2018·2018-06-13

    Tosoh ST-AIA PACK hsE2 Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK hsE2 assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2018·2018-06-13

    Tosoh ST-AIA PACK AFP Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK AFP assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2018·2018-06-13

    Tosoh ST-AIA PACK HGH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HGH assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2018·2018-06-13

    Tosoh ST-AIA PACK CK-MB Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK CK-MB assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2018·2018-06-13

    Tosoh ST-AIA PACK CEA Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK CEA assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2018·2018-06-13

    Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2018·2018-06-13

    Tosoh Prolactin Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Prolactin assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK BMG tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2018·2018-06-13

    Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Testosterone assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

    Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2018·2018-06-13

    Tosoh ST-AIA CA 19-9 Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK CA 19-9 assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2018·2018-06-13

    Tosoh FSH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2018·2018-06-13

    Tosoh ST-AIA PACK LH II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK LH II assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK TT3 thyroid assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2018·2018-06-13

    Tosoh ST-AIA PACK cTnI 2nd Gen Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK cTnI 2nd Gen assays because the drug Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2018·2018-06-13

    Tosoh ST-AIA PACK HCG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide