Recall Z-0220-2016 ยท LDT
Dako North America Inc.
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
| Date | Nov 5, 2015 (initiated Sep 4, 2015) |
| Status | Terminated |
| Reason | There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results. |
| Root cause | Other |
| Action | Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions s |
| Quantity | 300 units |
| Distribution | Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.