Microbiologics recalls Helix Elite Inactivated Standard (HE0071N/HE0073N) due to not being registered for UK use. Consumers should check labels for UDI numbers and expiration dates.
Product not registered for use in the UK
Microbiologics is recalling its Helix Elite Inactivated Standard COVID-19 test kits because they were not registered for use in the UK. This means the products may not meet UK safety standards and could pose risks if used there.
The products were not registered for use in the UK, meaning they may not meet UK safety standards. This could lead to improper testing results or other issues if used in the UK without proper registration.
UK consumers who own or use these specific test kits with UDI numbers 10845357043846 or 10845357043945 are likely affected. Those using the products outside the UK may face no risk.
Check the label for UDI numbers: 10845357043846 (HE0071N) or 10845357043945 (HE0073N). Also look for expiration dates: 12/31/2022 or 02/28/2023.
Look for UDI numbers 10845357043846 or 10845357043945 on the product label.
The product was not registered for use in the UK, so it may not meet UK safety standards.
Check the label for UDI numbers 10845357043846 (HE0071N) or 10845357043945 (HE0073N).
The recall record does not specify a remedy, so no action is required beyond checking the label.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1740-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-1740-2022 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.
