Lower riskMedical device recall · FDA · Published February 20, 2025
Microbiologics Helix Elite Inactivated SARS-CoV-2 Standard: Late Ct Value Risk
Microbiologics recalls Helix Elite Inactivated SARS-CoV-2 Standard due to potential late Ct values in A549 cell testing. Affected units include specific catalog and lot numbers.
“Microbiologics Helix Elite Inactivated SARS-CoV-2 Standard: Late Ct Value Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52787-microbiologics-helix-elite-inactivated-sars-cov-2-standard-late-ct. Based on FDA recall #Z-1371-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2025%22&limit=1).
Microbiologics Inc voluntarily recalled Helix Elite Inactivated Standard SARS-CoV-2 Whole Virus control material on Feb. 20, 2025, according to the FDA. The recall addresses a hazard where the human cell target may give a late Ct value.
How to tell if you have it
Brand: Microbiologics
Product: Helix Elite Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material
Catalog Number: HE0065N
UDI-DI: 10845357043563
Lot Number: HE0065-29
The hazard
The A549 human cell target used for sample adequacy control may give a late Ct value.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls include the Dec. 2, 2025 KWIK-STIK 2-Pack recall for potential failure to recover Campylobacter jejuni and the Nov. 13, 2025 KWIK-STIK Quality Control Kit recall involving lot labeling mix-ups.
How to tell if you have this one
Check for the catalog number HE0065N and lot number HE0065-29 on the product label. This specific test material was sold by Microbiologics Inc.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number HE0065N and lot number HE0065-29 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the states of TX. UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is for potential inaccurate test results, not a direct safety hazard. The product is safe to use but may not give accurate results in some lab tests.
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-1371-2025 (February 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1371-2025 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.