Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker 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. The hazard involves potential diagnostic errors due to drug interference, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK PA (Part Number: 025263) Assay, Tumor Marker. The recall involves 41,105 units distributed worldwide, including the United States, Canada, Mexico, and several other countries in the Americas. All lot codes are affected.
The recall is being issued 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 using these assays should be aware of this potential for inaccurate results when patients are taking Strensiq. The source text does not specify specific consumer actions or report any illnesses or injuries.
The recalled product
- Product
- ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 41,105
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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