Ortho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference
Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.
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 biased diagnostic results rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Immunodiagnostic Products TSH Reagent Packs (Lot 1912997) due to a potential for biased test results. The recall involves 68,230 units distributed worldwide, including the United States and numerous international markets.
The recalling firm determined that specific VITROS Immunodiagnostic Products (MicroWell Assays) may produce biased results for patients taking biotin supplements. This interference can occur at biotin concentrations lower than those indicated in the current Instructions For Use (IFU). The hazard is limited to potential inaccuracies in diagnostic testing rather than a direct physical injury from the device itself.
Healthcare providers and laboratories should stop using the affected reagent packs and contact Ortho Clinical Diagnostics for further instructions. Patients who have recently taken biotin supplements and received TSH test results using these products should consult their healthcare provider to discuss the potential for biased results.
The recalled product
- Product
- VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 68,230
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ortho Clinical Diagnostics 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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