Zeus Scientific, Inc. is recalling 589 units of its Parvovirus B19 IgG and IgM ELISA Test Systems because a modification was made to a component called the 'conjugate' without required FDA review and approval. These diagnostic kits are used by healthcare professionals to detect antibodies to Parvovirus B19. Because the product improvement process was not validated by the FDA prior to implementation, the performance and reliability of these specific test lots cannot be guaranteed. Consumers should contact their healthcare provider if they have concerns about test results obtained using these kits.
The use of unapproved modifications in diagnostic test kits may result in inaccurate test results, which can lead to improper patient diagnosis or delayed treatment for Parvovirus B19 infections.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.