Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, 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 is classified as FDA Class II, and the hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patient care, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays (Part Number: 025287) due to interference from the medication Asfotase Alfa (Strensiq). The recall involves 4,027 units distributed worldwide, including the United States, Canada, Mexico, and several other countries in the Americas.
The recall is necessary because Asfotase Alfa interferes with certain Tosoh assays, which can potentially cause falsely increased or falsely decreased immunoassay test results depending on the specific assay used. This interference may lead to inaccurate diagnostic information for patients taking Strensiq.
Healthcare providers and laboratories should be aware of this potential interference when interpreting test results for patients on Asfotase Alfa. Consumers taking Strensiq should consult their healthcare provider regarding the potential impact on their lab test results.
The recalled product
- Product
- ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 4,027
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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