U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Reagent, general purpose - Product Code LDT
원인
The ph of target retrieval solution in the kit measures 4-5 instead of the correct ph of 9.1.
조치
A recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.
Worldwide Distribution -- US, Canada, and Colombia.
제품 설명
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. || Intended for use in immunohistochemistry together with Autostainer Link Instruments.