Manufacturer
74 recalls in our database name Tosoh Bioscience, Inc. as the manufacturing or recalling firm.
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.
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.
Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.
Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA SHBG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c reagents because the assay may produce erroneously high or low Hemoglobin A1c results.
Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.
Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.
Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.
Tosoh Bioscience is recalling ST AIA-PACK Prog II assay kits because DHEA-S supplements can cause falsely elevated progesterone results.
Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.
Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.
Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.
Tosoh Bioscience is recalling 64 boxes of AIA-PACK TgAb Control Set because the labels included instructions for a non-FDA approved methodology.
Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.
Tosoh Bioscience is recalling 682 HLC-723G8 analyzers because they may report inaccurate HbA1c values for patients with specific hemoglobin variants.
Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.
Tosoh Bioscience is recalling G7 Variant Elution Buffer HiS no. 1 (M) because it is labeled with an expiration date of October 2015 instead of the correct October 2014.
Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.