Tosoh ST-AIA PACK hsE2 Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK hsE2 assays because Asfotase Alfa (Strensiq) interferes with the test, 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. The hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 49 units of the ST-AIA PACK hsE2 (Part Number: 025225) Reproductive Hormone Assay. The recall is due to interference from Asfotase Alfa (Strensiq), which can cause falsely increased or decreased immunoassay test results.
The affected products were distributed worldwide, including the United States, Canada, Mexico, and various countries in Central and South America. The recall covers all lot codes for this specific product.
Healthcare providers and laboratories should stop using the affected assays and contact Tosoh Bioscience for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 49
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.
See all 35 products in this recall →Related recalls
Same manufacturer · Tosoh Bioscience Inc
See all →- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModerateTosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures
FDA (Devices) · 2021-03-17
- ModerateTosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- ModerateTosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- HighTosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect
FDA (Devices) · 2020-07-01
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighTosoh Bioscience Recalls Progesterone II Assay Kits Due to Cross-Reactivity
FDA (Devices) · 2018-03-07
- ModerateTosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits
FDA (Devices) · 2018-03-07
- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- HighTosoh Bioscience Recalls HbA1c Control Due to Erroneous Results
FDA (Devices) · 2018-05-23
- HighTosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits
FDA (Devices) · 2019-01-02
- ModerateTosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference
FDA (Devices) · 2019-01-02