Ortho VITROS Folate Reagent Pack Recall for Biotin Interference
Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.
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. The source text does not report any hospitalizations or injuries, and the hazard is a potential for biased test results rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 7,880 units of VITROS Immunodiagnostic Products - Folate Reagent Pack (10758750009237) 1513266. The affected products were distributed nationwide in the United States and in multiple countries worldwide, including Australia, Canada, China, Japan, and the United Kingdom.
The recall was initiated because the firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations lower than those indicated in the current Instructions For Use (IFU). Patients taking biotin supplements could potentially have biased sample results for the affected assays at these lower biotin concentrations.
This recall is classified as Class II by the FDA. The source text does not report any specific illnesses or injuries associated with this recall. Healthcare providers and laboratories should refer to the manufacturer for specific instructions on handling the affected reagent packs.
The recalled product
- Product
- VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 7,880
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)
- 2470 2480 2490 2501 2510 2521
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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