EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
FDA Recall Z-2330-2016 · Posted None
Recalling FirmDako Denmark A/S
Recall StatusTerminated
Product CodeLDT
Date Initiated2016-07-06
Date Terminated2016-10-13
Product Quantity147 kits
Reason for Recall
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- US, Canada, and Colombia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.