Ortho-Clinical Diagnostics recalls VITROS NT-proBNP Reagent (Cat No. 6802156) due to potential biased results at low biotin concentrations. This affects in vitro diagnostic testing for heart failure and cardiac risk assessment.
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 NT-proBNP Reagent (Cat No. 6802156) because it may produce inaccurate test results when biotin concentrations are lower than specified in the instructions. This could lead to incorrect heart failure diagnoses or risk assessments.
The reagent may produce biased results when biotin concentrations in samples are lower than what the current instructions specify. This could lead to inaccurate measurements of NT-proBNP, which is used to assess heart failure severity and cardiac risk.
Healthcare providers using the VITROS NT-proBNP Reagent for heart failure and cardiac risk testing are likely affected. Patients receiving these tests may be at risk of incorrect diagnosis if the reagent is used improperly.
Check for the product code 6802156 on the reagent vial. The reagent is used in heart failure and cardiac risk testing with VITROS ECi/ECiQ, 3600, or 5600 systems.
Verify the product code on the reagent vial to confirm it is 6802156.
The recall is due to potential biased results at biotin concentrations lower than indicated in the current Instructions for Use.
Inaccurate measurements of NT-proBNP could lead to incorrect heart failure diagnoses or risk assessments if the reagent is used with samples having lower biotin concentrations than specified.
Look for the product code 6802156 on the reagent vial. This reagent is used in heart failure and cardiac risk 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-0689-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0689-2019 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.
