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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Tosoh Bioscience Inc: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Agency Publication Date: June 5, 2018
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Affected Products

Product: ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

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Product: ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

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Product: ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker

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Product: ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

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Product: ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker

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Product: ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker

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Product: ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker

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Product: ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker

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Product: ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker

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Product: ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes

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Product: ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes

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Product: ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes

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Product: AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

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Product: ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid

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Product: ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid

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Product: ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid

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Product: ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

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Product: ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid

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Product: ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone

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Product: ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone

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Product: ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

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Product: ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

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Product: ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone

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Product: ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone

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Product: ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone

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Product: ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone

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Product: ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone

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Product: ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone

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Product: ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone

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Product: ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic

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Product: ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

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Product: ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia

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Product: ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy

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Product: ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker

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Product: ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79813
Status: Resolved
Manufacturer: Tosoh Bioscience Inc
Manufactured In: United States
Units Affected: 35 products (3254; 15942; 41105; 1083; 4824; 12361; 2549; 733; 5802; 1358; 2982; 9625; 5293; 10424; 14690; 12055; 43275; 5491; 12614; 66; 1442; 9033; 4867; 16080; 49; 10023; 5990; 539; 10913; 4027; 752; 24410; 2867; 3406; 1047)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.