Ortho Clinical Diagnostics recalls VITROS Folate Reagent Packs due to potential biased test results when patients take biotin supplements below the indicated concentration in the instructions.
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 Folate Reagent Packs because patients taking biotin supplements might get inaccurate test results. This could affect blood tests for certain conditions if the biotin levels are lower than what the instructions specify.
The test results could be biased if patients take biotin supplements at concentrations lower than what the instructions specify. This might lead to incorrect blood test outcomes for certain conditions.
Patients using VITROS Folate Reagent Packs who take biotin supplements may get inaccurate test results. Those with specific blood tests affected by biotin levels are most at risk.
Check for the VITROS Folate Reagent Pack with the model number 10758750009237. This product was sold in specific batches and models listed in the recall notice.
Look for the model number 10758750009237 on the VITROS Folate Reagent Pack.
Ortho Clinical Diagnostics determined that patients taking biotin supplements could get biased test results for specific VITROS Immunodiagnostic Products at biotin concentrations lower than indicated in the current Instructions For Use.
No, but you should check if you have the recalled model and consider discussing biotin use with your healthcare provider if you take supplements.
Check the model number on the product; if it matches 10758750009237, contact Ortho Clinical Diagnostics for guidance.
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-0058-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0058-2019 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.
