Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Pack (Cat No. 6801816) due to potential biased results at lower biotin concentrations than specified in instructions. This affects laboratory testing for hepatitis B.
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 Anti-HBe Reagent Pack (Cat No. 6801816) because it may produce inaccurate test results when biotin levels are lower than stated in the product instructions. This could lead to incorrect hepatitis B status assessments in laboratory testing.
The reagent pack may produce biased test results when biotin concentrations in samples are lower than indicated in the current Instructions for Use. This could lead to inaccurate hepatitis B status assessments, potentially affecting diagnosis and treatment decisions.
Laboratories using the VITROS Anti-HBe Reagent Pack for hepatitis B testing in adults and children aged 2-21 years may be affected. Patients with chronic hepatitis or those who have recovered from hepatitis B are most at risk of incorrect test results.
Check for the product code 6801816 on the VITROS Anti-HBe Reagent Pack. The product is used for in vitro testing of hepatitis B e antigen antibodies in human serum from individuals aged 2 to 21 years.
Verify the product code on the reagent pack is 6801816.
The recall is due to potential biased test results at biotin concentrations lower than indicated in the current Instructions for Use.
The reagent pack may produce inaccurate hepatitis B status assessments, which could affect diagnosis and treatment decisions.
The product is safe for use but may produce biased results if biotin concentrations are lower than specified in the instructions.
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-0687-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0687-2019 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.
