Tosoh Bioscience Recalls ST AIA-PACK ACTH In Vitro Diagnostic Reagents
Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the recall is voluntary, aligning with the criteria for a Moderate severity score.
Plain-English summary
Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH (Adrenocorticotropic Hormone) in vitro diagnostic reagents. The product is designed for the quantitative measurement of ACTH in human EDTA plasma to assist in the differential diagnosis and treatment of certain adrenal gland disorders, including Cushing's syndrome and adrenocortical insufficiency.
The recall was initiated by the firm on November 30, 2018, and was classified as Class II by the FDA. The source text does not specify the exact reason for the recall or report any specific injuries or illnesses associated with the use of the product. The recall covers all lots of the affected product.
The product was distributed nationwide in the United States. The recall was terminated on January 14, 2021. Healthcare facilities and laboratories that possess the recalled product should stop using it and contact Tosoh Bioscience Inc for instructions on return or disposal.
The recalled product
- Product
- 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 dis
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,085
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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