Ortho-Clinical Diagnostics recalls VITROS dLDL Reagent GENs 26 & 27 due to potential negative results. Affected units have specific lot numbers and expiration dates. Contact for replacement.
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Ortho-Clinical Diagnostics is recalling VITROS dLDL Reagent GENs 26 and 27 because they may produce negative results when measuring LDL cholesterol. This could lead to incorrect health assessments if used in medical testing.
The reagents may produce negative results when measuring LDL cholesterol, which could lead to incorrect health assessments. This might affect medical decisions if the test results are used for diagnosis or treatment planning.
People who own or use these reagents for LDL cholesterol testing in medical labs or clinical settings. Those with recent test results using the affected lots are most at risk.
Check the product code 6801728 and lot numbers 1517-26-6396 (expires Nov 2018), 1517-26-6582 (expires Feb 2019), 1517-26-6639 (expires Feb 2019), or 1517-27-6808 (expires May 2019).
Identify the lot number and expiration date on the reagent packaging.
The reagents may produce negative results when measuring LDL cholesterol, which could lead to incorrect health assessments.
Lots 1517-26-6396 (expires Nov 2018), 1517-26-6582 (expires Feb 2019), 1517-26-6639 (expires Feb 2019), and 1517-27-6808 (expires May 2019).
No, but you should check the lot numbers to ensure you have the correct version for your tests.
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-0476-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0476-2019 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.
