Tosoh Anemia Assay Recalled Due to Interference from Strensiq Medication
Tosoh Bioscience is recalling ST-AIA PACK Fer assays because the medication Strensiq can cause inaccurate test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where inaccurate test results could lead to clinical mismanagement, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK Fer (Part Number: 025253) Assay, Anemia. The recall affects 24,410 units distributed in the United States, Canada, Mexico, and several other countries in the Americas.
The recall was initiated 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 Strensiq may experience inaccurate results when tested with this specific product. Users should consult with Tosoh Bioscience for further guidance on handling affected lots.
The recalled product
- Product
- ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 24,410
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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