Ortho Clinical Diagnostics recalls VITROS Prolactin Reagent Packs due to potential biased test results when patients take biotin supplements. Affected units have specific model numbers and were sold in certain regions.
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Ortho Clinical Diagnostics is recalling VITROS Prolactin Reagent Packs because biotin supplements might cause inaccurate test results for some patients. This could lead to incorrect health assessments if the patient's biotin levels are below what the test expects.
The test may give incorrect results if a patient's biotin concentration is lower than what the test expects. This happens because the current instructions for use don't account for low biotin levels, which can occur with biotin supplements.
Patients using VITROS Prolactin Reagent Packs who take biotin supplements may experience inaccurate test results. Those with specific biotin levels lower than the test's requirements are most at risk.
Check for the model number 10758750000111 on the VITROS Prolactin Reagent Pack. The product was sold in specific regions and may have been purchased between 2023 and 2024.
If you take biotin supplements, review your recent test results for accuracy, as the test might show incorrect values.
Ortho Clinical Diagnostics determined that biotin supplements could cause biased results for specific VITROS Prolactin Reagent Packs when biotin levels are lower than indicated in the current Instructions For Use.
No, but if you take biotin supplements, you should check your test results for accuracy.
The affected model number is 10758750000111.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0060-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0060-2019 from Ortho Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
