EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse

FDA device recall Z-0220-2016 · posted 2015-11-05 · Terminated

Recall details

Recalling firm

Dako North America Inc.

Reason for recall

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.

Action taken

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 should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.

Root cause

Other

Status

Terminated

Product code

LDT

Quantity affected

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, a

Date initiated

2015-09-04

Date posted

2015-11-05

Date terminated

2016-04-25

Location

Carpinteria, CA