PlainRecalls
FDA Devices Moderate 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.

Reported: January 2, 2019 Initiated: November 30, 2018 #Z-0676-2019

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.

Details

Recalling Firm
Tosoh Bioscience Inc
Units Affected
1085 units
Distribution
US Nationwide
Location
Grove City, OH

Frequently Asked Questions

What product 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.. Recalled by Tosoh Bioscience Inc. Units affected: 1085 units.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0676-2019.