FDA Enforcement
Class II
Ongoing
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Recall: Z-0603-2024
·
Reported December 27, 2023
Enforcement
- Recall Number
- Z-0603-2024
- Event ID
- 93514
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Zeus Scientific, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2023
- Initiation Date
- October 31, 2023
- Classification Date
- December 21, 2023
- Address
- 199 Evans Way, N/A, Branchburg, NJ, 08876-4600, United States
Description
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.
Code Info
UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239
Distribution
US States: CA, MA, MI, NJ, NY, TN, UT.
Quantity
293 kits