Ortho Clinical Diagnostics recalls VITROS FSH Reagent Packs with specific lot numbers due to potential biased test results when biotin supplements are used at lower concentrations than indicated in the current 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 FSH Reagent Packs because patients taking biotin supplements may get inaccurate test results. This affects people who use these tests for fertility monitoring and take biotin supplements.
The reagent packs may produce biased results for certain fertility tests when biotin levels in the blood are lower than what the current instructions specify. This can happen if someone takes biotin supplements, which are common for hair and skin health.
People using VITROS FSH Reagent Packs for fertility testing who take biotin supplements are most at risk. The recall affects individuals who have the specific lot numbers listed in the recall notice.
Check the product label for the lot number 10758750000302. The recall applies to VITROS FSH Reagent Packs sold with specific model numbers.
Look for the lot number 10758750000302 on the VITROS FSH Reagent Pack.
Ortho Clinical Diagnostics determined that biotin supplements could cause biased test results for specific fertility tests when biotin levels are lower than indicated in the current instructions.
No, but you should check if you have the specific lot number mentioned in the recall. If you do, contact Ortho Clinical Diagnostics for further instructions.
Check the product label for the lot number 10758750000302. If you have it, contact Ortho Clinical Diagnostics for guidance on next steps.
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-0059-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0059-2019 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.
