Ortho Clinical Diagnostics recalls VITROS TSH Reagent Packs due to potential biased results when patients take biotin supplements. Affected units may show inaccurate test results for specific assays.
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 TSH Reagent Packs that could produce biased test results if patients take biotin supplements. This means some lab tests might be inaccurate for people using biotin supplements.
The test results could be biased when biotin concentrations in the patient's blood are lower than what the current instructions specify. This happens because the reagent pack is designed to work with specific biotin levels, and biotin supplements can alter those levels.
People who use VITROS TSH Reagent Packs for lab testing and take biotin supplements may have inaccurate test results. Those with biotin supplements are most at risk of incorrect results.
Check for the model number 10758750000227 on the VITROS TSH Reagent Pack. The product was sold in the U.S. and is part of the VITROS Immunodiagnostic Products line.
If you take biotin supplements, verify if your test results could be affected by this recall.
Ortho Clinical Diagnostics determined that biotin supplements could cause biased results for specific VITROS TSH Reagent Packs at biotin concentrations lower than indicated in the current Instructions For Use.
No, but if you take biotin supplements, you should check if your test results might be affected.
Look for the model number 10758750000227 on the VITROS TSH Reagent Pack.
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-0061-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0061-2019 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.
