FDAFDA · Food and drugs·Recall number Z-0676-2019
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.
Published January 2, 2019 · Recall initiated: November 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tosoh Bioscience Inc
- Distributor
- US Nationwide
- Lot
- all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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