Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative…

Recall date
November 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0676-2019
FDA classification
Class II
Brand / firm
Tosoh Bioscience Inc
Sold / distributed
US Nationwide

What was recalled

ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

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