Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker 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 medical device that can produce inaccurate test results, which poses a risk of harm to patients through misdiagnosis or inappropriate treatment. No specific injuries or illnesses are reported in the source text, but the potential for harm from false results places this in the High severity category.
Plain-English summary
Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 (Part Number: 025202) Assay, Tumor Marker. The recall involves 12,361 units distributed nationwide in the United States and in Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Honduras, Equador, Caymen Islands, Panama, and Costa Rica. All lot codes are affected.
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 assays and contact Tosoh Bioscience Inc. 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 27.29; Part Number: 025202 Assay, Tumor Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 12,361
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 · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModerateTosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits
FDA (Devices) · 2018-03-07
- HighTosoh Bioscience Recalls Progesterone II Assay Kits Due to Cross-Reactivity
FDA (Devices) · 2018-03-07
- HighTosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction
FDA (Devices) · 2018-11-21
- HighTosoh Bioscience Recalls HbA1c Control Due to Erroneous Results
FDA (Devices) · 2018-05-23
- ModerateTosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference
FDA (Devices) · 2019-01-02