Ortho-Clinical Diagnostics recalls VITROS HBeAg Reagent (Cat. No 6801819) due to potential biased results at lower biotin concentrations than specified in instructions. This affects lab tests for hepatitis B e antigen in blood samples.
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
Ortho-Clinical Diagnostics is recalling VITROS HBeAg Reagent (Cat. No 6801819) because it may produce inaccurate test results when biotin levels in samples are lower than what the instructions specify. This could lead to incorrect hepatitis B diagnoses in lab tests.
The reagent may give biased results when biotin concentrations in blood samples are lower than the levels indicated in the product's instructions. This could lead to incorrect hepatitis B e antigen test results, potentially affecting diagnosis decisions.
Lab users testing blood samples for hepatitis B e antigen with the VITROS system are affected. Patients with hepatitis B or at risk for HBV infection who undergo these tests may be impacted.
Check for the product code 6801819 on the VITROS HBeAg Reagent. This reagent is used in labs for hepatitis B e antigen testing with VITROS ECi/ECiQ, 3600, or 5600 systems.
Verify the product code on the reagent label to confirm it is 6801819.
The reagent is safe to use but may produce inaccurate results if biotin levels in samples are lower than specified in the instructions.
Using this reagent could lead to biased test results at lower biotin concentrations than indicated, potentially causing incorrect hepatitis B diagnoses.
Look for the product code 6801819 on the VITROS HBeAg Reagent label, which is used in labs for hepatitis B e antigen testing with VITROS ECi/ECiQ, 3600, or 5600 systems.
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-0688-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0688-2019 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.
