Z-0676-2019 Class II Terminated
FDA device recall Z-0676-2019 was initiated by Tosoh Bioscience Inc on November 30, 2018 and is designated Class II. The recall status is terminated (terminated January 14, 2021). Affected quantity: 1085 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 30, 2018
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1085 units
Product 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.
Distribution Pattern
US Nationwide
Code Information
all lots