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: 296 kits Lot/code info: UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218
00845533001748, 00845533001755, 00845533001779
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.