Microbiolog: Helix Elite Inactivated Standard (HE0044N) may give late Ct values in RSV testing, causing QC failures. Affected units include specific lot numbers and catalog codes.
The RSV target may give a late Ct value and could potentially not pass QC.
Microbiologics is recalling its Helix Elite Inactivated Standard test kit because the RSV target might produce late Ct values, potentially failing quality control checks. This could lead to inaccurate test results if used without proper validation.
The RSV target in this test kit may produce late Ct values, which can cause the test to fail quality control checks. This means the test might not work properly, leading to inaccurate results for influenza and RSV testing.
Laboratories using the Helix Elite Inactivated Standard (HE0044N) with lot number HE0044-131 or UDI-DI 10845357042184 are affected. Lab technicians handling this specific test kit are most at risk of inaccurate results.
Check for the catalog number HE0044N, lot number HE0044-131, or UDI-DI 10845357042184 on the test kit. This specific version of the Helix Elite Inactivated Standard is affected.
Verify the catalog number (HE0044N), lot number (HE0044-131), and UDI-DI (10845357042184) on the test kit.
The RSV target may give late Ct values, potentially causing the test to fail quality control checks.
Check the catalog number, lot number, and UDI-DI to confirm if it's affected. No specific action is required beyond verification.
No, this is a low-risk issue related to test accuracy, not physical safety.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1454-2025 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-1454-2025 from Microbiologics. 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.
