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.
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Microbiologics is recalling its Helix Elite Inactivated SARS-CoV-2 Standard test material because it may produce late Ct values in A549 cell testing. This could affect the accuracy of some laboratory tests.
The A549 human cell target in the test may give a late Ct value, which can lead to inaccurate results in some laboratory tests. This is a technical issue related to the test's performance.
Laboratories using this specific test material for SARS-CoV-2 testing are affected. Researchers and labs handling the product are most at risk.
Check for the catalog number HE0065N and lot number HE0065-29 on the product label. This specific test material was sold by Microbiologics Inc.
Look for the catalog number HE0065N and lot number HE0065-29 on the product label.
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 recall does not specify a remedy, so no action is required beyond checking the product details.
Check for the catalog number HE0065N and lot number HE0065-29 on the product label.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1371-2025 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-1371-2025 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.
