Tosoh ST-AIA PACK cTnI 2nd Gen Recalled Due to Drug Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK cTnI 2nd Gen assays because the drug Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate 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. The hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK cTnI 2nd Gen assay, Part Number 025205. The recall involves 5,802 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 the drug Asfotase Alfa (Strensiq) interferes with certain Tosoh assays. This interference potentially causes falsely increased or falsely decreased immunoassay test results, depending on the specific assay used.
Healthcare providers and laboratories should stop using the affected product and contact Tosoh Bioscience Inc for further instructions. Patients should consult their healthcare providers regarding any test results obtained using this specific assay.
The recalled product
- Product
- ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 5,802
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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