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.
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: US States: CA, MA, MI, NJ, NY, TN, UT. Quantity: 293 kits 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
00845533001724, 00845533001748
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.