medical Class II Updated 2023-12-27

Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM

Recalled Product

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, MA, MI, NJ, NY, TN, UT
Lot/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
View official government recall

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