Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM Test System (Product Number SM9Z7701G) due to unapproved conjugate modification. Affected units include specific lot numbers and UDI codes. No remedy is stated in the recall notice.
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 IgM Test System (Product Number SM9Z7701G) because the conjugate used in the test was modified without FDA approval. This could potentially lead to inaccurate test results if the test is used without proper regulatory oversight.
The conjugate in the test was modified without FDA approval, which could result in inaccurate test results. This means the test might not correctly detect Parvovirus B19 IgM, potentially leading to incorrect health decisions.
Users of the ZEUS ELISA Parvovirus B19 IgM Test System with Product Number SM9Z7701G and specific lot numbers (23030069, 23060238, 23060239) are affected. Healthcare providers and labs using this test system are most at risk.
Check the product number SM9Z7701G and lot numbers 23030069, 23060238, or 23060239 on the test system. The unique device identifier (UDI) codes are also listed in the recall notice.
Verify the product number and lot numbers to confirm if your test system is affected.
The conjugate in the test was modified without FDA approval, which could lead to inaccurate test results.
Lot numbers 23030069, 23060238, and 23060239 are affected.
The recall notice does not state any remedy or action steps for affected users.
We’ve drafted a message you can send Zeus Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0603-2024 — Zeus Scientific Zeus Scientific Hello, I own a Zeus Scientific that is covered by recall Z-0603-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
