Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for inaccurate test results due to drug interference, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/interference issues without reported harm.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK Prog II (Part Number: 025239), a reproductive hormone assay. The recall involves 5,990 units distributed nationwide in the United States and in various countries in the Americas, including Canada, Mexico, and several South and Central American nations.
The recall is being conducted because Asfotase Alfa (Strensiq) interferes with certain Tosoh assays. This interference can potentially cause falsely increased or falsely decreased immunoassay test results, depending on the specific assay used.
Healthcare providers and laboratories should be aware that patients taking Asfotase Alfa may have inaccurate test results when using this specific assay. The source text does not specify further consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 5,990
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 Lot Codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 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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