Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate 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 diagnostic) where inaccurate results could lead to clinical errors, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 1,047 units of ST-AIA PACK Cystatin C (Part Number: 025217), a kidney marker assay. The recall covers all lot codes and includes products 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 stop using the affected ST-AIA PACK Cystatin C assays and contact Tosoh Bioscience Inc for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,047
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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