Recall Z-0603-2024— Zeus Scientific, Inc.
Class II · Ongoing
Class II FDA medical device recall by Zeus Scientific, Inc., initiated 2023-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G. Reason: 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..
- Recalling firm
- Zeus Scientific, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-31
- Firm location
- Branchburg, NJ, United States
Product description
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.