Microbiologics Helix Elite Inactivated Standard Recall: RSV Target May Give Late Ct Values
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.
Lower-risk recall
The RSV target may give a late Ct value and could potentially not pass QC.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/52788-microbiologics-helix-elite-inactivated-standard-recall-rsv-target-may-give.
Source Summary by GovInfoNow · govinfonow.com/recall/52788-microbiologics-helix-elite-inactivated-standard-recall-rsv-target-may-give · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1454-2025
Cite this page
“Microbiologics Helix Elite Inactivated Standard Recall: RSV Target May Give Late Ct Values.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52788-microbiologics-helix-elite-inactivated-standard-recall-rsv-target-may-give. Based on FDA recall #Z-1454-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1454-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Microbiologics- Category
Medical device
What to do — step by step
Check Kit Details
Verify the catalog number (HE0044N), lot number (HE0044-131), and UDI-DI (10845357042184) on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Kentucky, Montana, New Jersey, New York, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this test kit?
Check the catalog number, lot number, and UDI-DI to confirm if it's affected. No specific action is required beyond verification.
Is there a risk of injury from this test kit?
No, this is a low-risk issue related to test accuracy, not physical safety.
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Where this comes from
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.
- Official source: FDA Recall #Z-1454-2025 (February 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1454-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.