Tosoh Myoglobin Assay Recalled Due to Drug Interference
Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug 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 inaccurate medical test results due to drug interference, which poses a risk of harm to patients through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 733 units of the ST-AIA PACK Myoglobin assay (Part Number: 025297). This product is a cardiac marker assay used for medical testing. The recall covers all lot codes and includes units distributed worldwide, including the United States, Canada, Mexico, and various countries in South and Central America.
The recall was initiated because the drug 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. Inaccurate test results may impact clinical decision-making.
Healthcare providers and laboratories should stop using the affected ST-AIA PACK Myoglobin assays. Consumers and patients should consult their healthcare providers regarding any recent test results that may have been affected by this interference.
The recalled product
- Product
- ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 733
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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