Tosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference
Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a potential for inaccurate test results due to interference rather than a direct physical injury or contamination, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 29,645 units of AIA-PACK B12 (Vitamin B12) reagents. These products are designed for in vitro diagnostic use only to measure Vitamin B12 levels in human serum on Tosoh AIA System analyzers. The recall covers all lots and was distributed nationwide in the United States.
The recall was initiated due to a potential for fluorescein interference, which may cause inaccurately elevated results for certain Tosoh AIA assays. This issue could lead to incorrect diagnostic readings for patients tested with the affected reagents.
Healthcare facilities and laboratories that purchased or received these products should stop using them and contact Tosoh Bioscience Inc for further instructions on return or replacement. Consumers are not directly affected as this is a professional in vitro diagnostic product.
The recalled product
- Product
- AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 29,645
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 lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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