Tosoh ST-AIA PACK HGH Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK HGH assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 patients, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Tosoh Bioscience Inc is recalling 752 units of ST-AIA PACK HGH (Part Number: 025266) assays. The recall is due to interference from the drug Asfotase Alfa (Strensiq), which can cause falsely increased or decreased immunoassay test results depending on the specific assay.
The affected products were distributed worldwide, including the United States, Canada, Mexico, and various countries in South and Central America. All lot codes are included in this recall.
Healthcare providers and laboratories should stop using the affected assays and contact Tosoh Bioscience Inc for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 752
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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