Z-0603-2024 Class II Ongoing
FDA device recall Z-0603-2024 was initiated by Zeus Scientific, Inc. on October 31, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 293 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293 kits
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.
Distribution Pattern
US States: CA, MA, MI, NJ, NY, TN, UT.
Code Information
UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239