Recall Z-2330-2016 ยท LDT
Dako Denmark A/S
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
| Date | Jul 6, 2016 |
| Status | Terminated |
| Reason | The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. |
| Root cause | Process control |
| 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 |
| Quantity | 147 kits |
| Distribution | Worldwide Distribution -- US, Canada, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.