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Recall Observatory FDA recall evidence

Device product

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.

Z-0676-2019

November 30, 2018

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 81597
Status
Terminated
Classification
Class II
Quantity
1085 units
Official record key
device-enforcement:Z-0676-2019

Official wording

Reason: Unavailable

Code information: all lots

Distribution pattern: US Nationwide