Device product

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

Z-0603-2024

October 31, 2023

Class II

Product summary

Firm: Zeus Scientific, Inc.
Event: Event 93514
Status: Ongoing
Classification: Class II
Quantity: 293 kits
Official record key: device-enforcement:Z-0603-2024

Official wording

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 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

Distribution pattern: US States: CA, MA, MI, NJ, NY, TN, UT.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.