BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Recall of DakoCytomation for Envision Plus Visualization Reagent

Product group In-vitro diagnostics
Reference 02681/05

Recall of DakoCytomation for Envision Plus Visualization Reagent (EnVision, Mouse: Item: K400011-2, lot number 065021 and 085031; Item: K4001: lot number 045036, 065022 and 085032; Item: K4005, lot number 035194, 055030 and 065142; Item: K4006, lot number 045172 and 075112 as well as Item: K4007, lot number 045173 and 075113 as well as EnVision, Rabbit: Item: K400211-2, lot number 045037 and 065139; Item: K4003, lot number 045038 and 065140; Item K4008, lot number 085146 and 065143; Item: K4009, lot number 045175, 065144 and 085147; Item: K4010, lot number 035293, 055031 and 075114; as well as Item: K4011, lot number 035196, 055032 and 075115) because of an incorrect reagent composition which causes an insufficient staining quality. Customers were informed to discard the affected batches.

Recall of DakoCytomation for Envision Plus Visualization Reagent , Download_VeroeffentlichtAm_EN PDF, 30KB,