FDA Enforcement
Class II
Terminated
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.
Recall: Z-0676-2019
·
Reported January 2, 2019
Enforcement
- Recall Number
- Z-0676-2019
- Event ID
- 81597
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 2, 2019
- Initiation Date
- November 30, 2018
- Classification Date
- December 22, 2018
- Termination Date
- January 14, 2021
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895, United States
Description
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.
Code Info
all lots
Distribution
US Nationwide
Quantity
1085 units