Home / Recalls / Tosoh Bioscience Inc / Z-0676-2019

Z-0676-2019 Class II Terminated

Recalled by Tosoh Bioscience Inc — Grove City, OH

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

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Z-2423-2020 Class II — AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 (May 22, 2020)
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Z-0675-2019 Class II — ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for (November 30, 2018)
Z-0672-2019 Class II — AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quant (November 30, 2018)
Z-0671-2019 Class II — AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the (November 30, 2018)
Z-0673-2019 Class II — ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC (November 30, 2018)
Z-0674-2019 Class II — ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for (November 30, 2018)
Z-0509-2019 Class II — AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product (October 5, 2018)