Tosoh Prolactin Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK Prolactin 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 involves a risk-of-harm product (medical diagnostic) where inaccurate results could lead to misdiagnosis or inappropriate treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 4,867 units of the ST-AIA PACK Prolactin assay (Part Number: 025255). 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 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 should stop using the affected Prolactin assays and contact Tosoh Bioscience for further instructions. Patients who have received test results using these assays should consult their healthcare provider to discuss the potential impact of the interference on their results.
The recalled product
- Product
- ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 4,867
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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