Tosoh Thyroid Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test 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, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling ST-AIA PACK TU (Part Number: 025270) thyroid assays. The recall involves 5,491 units distributed in the United States and several countries in the Americas, including Canada, Mexico, and various Central and South American nations.
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 products and contact Tosoh Bioscience Inc for further instructions. Patients should consult their healthcare providers regarding any thyroid test results obtained using these assays.
The recalled product
- Product
- ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 5,491
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 →- 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
- HighGEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05