Ortho VITROS Prolactin Reagent Pack Recalled for Biotin Interference
Ortho Clinical Diagnostics is recalling VITROS Prolactin 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 source text describes a potential for biased results without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 1,790 units of VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793. The affected products were distributed nationwide in the US and in numerous countries worldwide, including Australia, Canada, China, 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.
No specific lot numbers or expiration dates are provided in the source text. Healthcare facilities and laboratories should contact Ortho Clinical Diagnostics for further instructions on handling the recalled reagent packs.
The recalled product
- Product
- VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 1,790
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)
- 2330 2340 2350 2360 2370 2380
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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