Tosoh ST-AIA PACK CEA Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK CEA 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 ST-AIA PACK CEA assays, Part Number 025254. The recall involves 15,942 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 was initiated because Asfotase Alfa (Strensiq) interferes with certain Tosoh assays. This interference potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the specific assay.
Healthcare providers and laboratories should stop using the affected ST-AIA PACK CEA assays and contact Tosoh Bioscience Inc for further instructions regarding the recall and replacement of the product.
The recalled product
- Product
- ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 15,942
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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