Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgG Test System (Product Number SM9Z7701M) due to unapproved conjugate modification. Affected units include specific lot numbers and UDI codes. Consumers should contact Zeus for details.
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Zeus Scientific is recalling its ZEUS ELISA Parvovirus B19 IgG Test System (Product Number SM9Z7701M) because a conjugate modification was made without FDA approval. This could pose a risk to test accuracy and results.
The recall is due to a conjugate modification in the test system that was not reviewed and approved by the FDA before implementation. This unapproved change could affect the accuracy and reliability of the test results.
Anyone who purchased or uses the ZEUS ELISA Parvovirus B19 IgG Test System with the specified product number and lot numbers. Laboratory users and healthcare professionals are most at risk.
Check for the product number SM9Z7701M and lot numbers 23030068, 23060217, or 23060218. The unique device identifier (UDI) codes listed in the recall notice also help identify affected units.
Reach out to Zeus Scientific for specific instructions on how to handle the recalled product.
The conjugate modification in the test system was not reviewed and approved by the FDA prior to implementation.
Contact Zeus Scientific for specific instructions on how to handle the recalled product.
Check for the product number SM9Z7701M and lot numbers 23030068, 23060217, or 23060218.
We’ve drafted a message you can send Zeus Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0602-2024 — Zeus Scientific Zeus Scientific Hello, I own a Zeus Scientific that is covered by recall Z-0602-2024 from Zeus Scientific. 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.
