Tosoh Bioscience Recalls ST AIA-PACK Homocysteine Diagnostic Reagents
Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a situation that could cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the hazard is not explicitly detailed, fitting the criteria for a moderate severity score.
Plain-English summary
Tosoh Bioscience Inc is voluntarily recalling 992 units of ST AIA-PACK Homocysteine (HCY) reagents. These products are designed for in vitro diagnostic use only to measure homocysteine levels in human serum, heparinized plasma, or EDTA plasma on TOSOH AIA System Analyzers. The recall includes all lots of the product.
The recall was initiated by the firm on November 30, 2018, and was classified as Class II by the FDA. The products were distributed nationwide in the United States. The source text does not specify the exact reason for the recall or report any specific illnesses or injuries associated with the use of these reagents.
Healthcare facilities and laboratories that have purchased these reagents should stop using them and contact Tosoh Bioscience Inc for further instructions. The recall was terminated on January 14, 2021.
The recalled product
- Product
- ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of…
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 992
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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