ZEUS ELISA Parvovirus B19 IgG Test SystemRecalls & reported problems across all models

We found 2 models of ZEUS ELISA Parvovirus B19 IgG Test System by Zeus Scientific, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ZEUS ELISA Parvovirus B19 IgG Test System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 31, 2023Class IIOpen, Classified

   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.

   Z-0603-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

2. Oct 31, 2023Class IIOpen, Classified

   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.

   Z-0602-2024 · Root cause: Device Design · Recall details · FDA record ↗

ZEUS ELISA Parvovirus B19 IgG Test System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZEUS ELISA Parvovirus B19 IgG Test System SM9Z7701G
  2 recalls0 reports
• ZEUS ELISA Parvovirus B19 IgG Test System 9Z7701G
  1 recall0 reports